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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004703-23 | EudraCT Number |
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This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients with either hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), healthcare-associated pneumonia (HCAP), complicated urinary tract infection (cUTI), or bloodstream infections (BSI)/sepsis caused by carbapenem-resistant Gram-negative pathogens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefiderocol | Experimental | Participants will receive cefiderocol 2 g administered intravenously over 3 hours, every 8 hours for 7-14 days. Treatment could be extended to 21 days at the discretion of the investigator. |
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| Best Available Therapy (BAT) | Active Comparator | Best available therapy (BAT) will be chosen by the investigator and may include up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. Treatment could be extended to 21 days at the discretion of the investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefiderocol | Drug | 2 g intravenously over 3 hours every 8 hours for a period of 7 to 14 days, or 2 g every 6 hours for participants with creatinine clearance >120 mL/min. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. Participants with missing data were considered as non-responders. | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Percentage of Participants With Microbiologic Eradication at TOC in Participants With cUTI | Microbiological outcome per Baseline pathogen was determined by the sponsor as defined for each infection site. For cUTI eradication was defined as a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ colony-forming units (CFU)/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Test of cure, defined as 7 days after the end of treatment, equivalent to Study Days 14 to 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With HAP/VAP/HCAP or BSI/Sepsis | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. |
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Inclusion Criteria:
Patients with clinically documented infection (HAP/VAP/HCAP, cUTI, or BSI/sepsis) caused by a Gram-negative pathogen with evidence of carbapenem resistance
Patients who have been treated previously with an empiric antibiotic regiment and failed treatment, both clinically and microbiologically, are eligible for the study, if they have an identified carbapenem-resistant Gram-negative pathogen which has either been shown to be nonsusceptible in vitro to each of the antibiotic(s) of the empiric antibiotic regimen or been grown from a culture performed after at least 2 days of the empiric antibiotic regimen
Patient is male (no contraception required) or female and meets one of the following criteria:
Patients meeting specific criteria for each infection site
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shionogi Research Site | Hartford | Connecticut | 06102 | United States | ||
| Shionogi Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35076335 | Derived | Nordmann P, Shields RK, Doi Y, Takemura M, Echols R, Matsunaga Y, Yamano Y. Mechanisms of Reduced Susceptibility to Cefiderocol Among Isolates from the CREDIBLE-CR and APEKS-NP Clinical Trials. Microb Drug Resist. 2022 Apr;28(4):398-407. doi: 10.1089/mdr.2021.0180. Epub 2022 Jan 24. | |
| 34792787 | Derived | Wenzler E, Butler D, Tan X, Katsube T, Wajima T. Pharmacokinetics, Pharmacodynamics, and Dose Optimization of Cefiderocol during Continuous Renal Replacement Therapy. Clin Pharmacokinet. 2022 Apr;61(4):539-552. doi: 10.1007/s40262-021-01086-y. Epub 2021 Nov 18. |
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Participants were randomized in a 2:1 ratio to receive therapy with cefiderocol or best available therapy (BAT), stratified by primary clinical diagnosis (HAP/VAP/HCAP, BSI/sepsis, cUTI), Acute Physiology and Chronic Health Evaluation (APACHE) II score (≤ 15 or ≥ 16-≤ 30), and region (North America, South America region, Europe, Asia-Pacific).
This study enrolled hospitalized patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), healthcare-associated pneumonia (HCAP), bloodstream infection (BSI), sepsis, or complicated urinary tract infection (cUTI) caused by carbapenem-resistant Gram-negative pathogens, and was conducted at 95 sites in 16 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| FG001 | Best Available Therapy (BAT) | Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2019 | Oct 20, 2020 |
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| Best Available Therapy | Drug | Standard of care with either a polymyxin-based or non-polymyxin-based regimen as determined by the investigator and consisting of one to three marketed antibacterial agent(s). |
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| End of treatment, Day 7 to 14 |
| Percentage of Participants With Sustained Clinical Cure at Follow-up (FU) in Participants With HAP/VAP/HCAP or BSI/Sepsis | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC. BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| Percentage of Participants With Clinical Cure at Test of Cure in Participants With cUTI | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With cUTI | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | End of treatment, Day 7 to 14 |
| Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With cUTI | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| Percentage of Participants With Clinical Cure at End of Treatment in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | End of treatment, Day 7 to 14 |
| Percentage of Participants With Clinical Cure at Test of Cure in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy is required for the treatment of pneumonia in a participant assessed as cured at TOC. BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy is required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC. cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| Percentage of Participants With Clinical Cure at End of Treatment By Baseline Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis: HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | End of treatment, Day 7 to 14 |
| Percentage of Participants With Clinical Cure at Test of Cure By Baseline Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC. BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC. cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| Percentage of Participants With Clinical Cure at EOT By Baseline Carbapenem-resistant Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis: HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | End of treatment, Day 7 to 14 |
| Percentage of Participants With Clinical Cure at TOC By Baseline Carbapenem-resistant Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis: HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Carbapenem-resistant Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC. BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC. cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| Percentage of Participants With Microbiologic Eradication at EOT in Participants With HAP/VAP/HCAP or BSI/Sepsis | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria established for each infection site: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | End of treatment, Day 7 to 14 |
| Percentage of Participants With Microbiologic Eradication at TOC in Participants With HAP/VAP/HCAP or BSI/Sepsis | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria established for each infection site: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With HAP/VAP/HCAP or BSI/Sepsis | Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. If an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. For sepsis, if the participant has a successful clinical outcome after TOC and an appropriate clinical culture could not be obtained, the response was presumed sustained eradication. Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| Percentage of Participants With Microbiologic Eradication at EOT in Participants With cUTI | Microbiological outcome per Baseline pathogen was determined by the sponsor as defined for each infection site. For cUTI eradication was defined as a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | End of treatment, Day 7 to 14 |
| Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With cUTI | Microbiological outcome per Baseline pathogen at follow-up was determined by the sponsor as defined for each infection site. For cUTI sustained eradication was defined as a culture taken any time after documented eradication at TOC and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained <10³ CFU/mL. Overall per-participant sustained eradication was defined as sustained eradication of all Baseline Gram-negative pathogens. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| Percentage of Participants With Microbiologic Eradication at EOT in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | End of treatment, Day 7 to 14 |
| Percentage of Participants With Microbiologic Eradication at TOC in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. For HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication. cUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained < 10³ CFU/mL. Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| Percentage of Participants With Microbiologic Eradication at EOT By Baseline Pathogen | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | End of treatment, Day 7 to 14 |
| Percentage of Participants With Microbiologic Eradication at TOC By Baseline Pathogen | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Pathogen | Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. For HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication. cUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained < 10³ CFU/mL. Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| Percentage of Participants With Microbiologic Eradication at EOT By Baseline Carbapenem-resistant Pathogen | Microbiological outcome per Baseline carbapenem-resistant pathogen were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | End of treatment, Day 7 to 14 |
| Percentage of Participants With Microbiologic Eradication at TOC By Baseline Carbapenem-resistant Pathogen | Microbiological outcome per Baseline carbapenem-resistant pathogen were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Carbapenem-resistant Pathogen | Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. For HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication. cUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained < 10³ CFU/mL. Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| Percentage of Participants With Microbiologic Eradication at EOT in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia | The percentage of participants who experienced eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture. | End of treatment, Day 7 to 14 |
| Percentage of Participants With Microbiologic Eradication at TOC in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia | The percentage of participants who experienced eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture. | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia | The percentage of participants who experienced sustained eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture after TOC. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| Percentage of Participants With a Composite Clinical and Microbiological Response at EOT | The composite clinical and microbiological response rate is defined as the percentage of participants with both clinical cure and microbiologic eradication, as defined above for each site of infection. | End of treatment, Day 7 to 14 |
| Percentage of Participants With a Composite Clinical and Microbiological Response at TOC | The composite clinical and microbiological response rate is defined as the percentage of participants with both clinical cure and microbiologic eradication, as defined above for each site of infection. | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Percentage of Participants With a Composite Clinical and Microbiological Response at Follow-up | The composite clinical and microbiological response rate is defined as the percentage of participants with both sustained clinical cure and sustained microbiologic eradication, as defined above for each site of infection. | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
| All-cause Mortality at Day 14 and Day 28 | The all-cause mortality rate at Day 14 and Day 28 was calculated as the percentage of participants who experienced mortality regardless of the cause at or before Day 14 and Day 28, respectively. | Day 14 and Day 28 |
| Percentage of Participants Alive and With No Change in Antibiotic Treatment Due to Either Lack of Therapeutic Benefit or Drug-related Toxicity at TOC | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
| Survival Time | Survival time was analyzed by Kaplan-Meier survival curve. The table below presents deaths that occurred in10-day time intervals through the end of study | Days 1 to 10, 11 to 20, 21 to 30, 31 to 40, 41-50, and 51 to 60. |
| Change From Baseline in Clinical Pulmonary Infection Score (CPIS) in Participants With Pneumonia (HAP/VAP/HCAP) | Clinical pulmonary infection score (CPIS) is a surrogate for diagnosis and treatment response. Points (0, 1, or 2) are assigned for observed findings for 5 variables including body temperature, white blood cell count, tracheal secretions, ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), and chest radiograph infiltrates. The total score ranges from 0 to 10, where higher scores may indicate a higher likelihood of mortality; a negative change from Baseline indicates improvement | Baseline, end of treatment (Day 7-14), test of cure (7 days after end of treatment, equivalent to Study Day 14 to 21) and follow-up (14 days after end of treatment, equivalent to Study Day 21 to 28) |
| Change From Baseline in Sequential Organ Failure Assessment (SOFA) | The SOFA score is a scoring system to determine the extent of a patient's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each score is from 0 to 4, and the total score ranges from 0 to 24, where higher scores indicate a higher likelihood of mortality. A negative change from Baseline score indicates improvement. | Baseline, end of treatment (Day 7 to 14), test of cure (7 days after end of treatment, equivalent to Study Day 14 to 21) and follow-up (14 days after end of treatment, equivalent to Study Day 21 to 28) |
| Number of Participants With Adverse Events | The severity of each adverse event (AE) was graded by the investigator according to the following definitions:
The relationship of AEs to study treatment was determined by the investigator according to the following definition: ● Related: An AE which can be reasonably explained as having been caused by the study treatment. A serious AE is defined as any AE that resulted in any of the following outcomes:
| From first dose of study drug up to 28 days after last dose; maximum treatment duration was 29 days in the cefiderocol group and 22 days in the BAT group. |
| Newark |
| Delaware |
| 19718 |
| United States |
| Shionogi Research Site | Chicago | Illinois | 60611 | United States |
| Shionogi Research Site | New Orleans | Louisiana | 70121 | United States |
| Shionogi Research Site | Detroit | Michigan | 48202 | United States |
| Shionogi Research Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Shionogi Research Site | Salvador | Estado de Bahia | 41810-011 | Brazil |
| Shionogi Research Site | Curitiba | Paraná | 80050 | Brazil |
| Shionogi Research Site | Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
| Shionogi Research Site | Porto Alegre | Rio Grande do Sul | 90035-074 | Brazil |
| Shionogi Research Site | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Shionogi Research Site | Santa Maria | Rio Grande do Sul | 97105-900 | Brazil |
| Shionogi Research Site | São José do Rio Preto | São Paulo | 15090 | Brazil |
| Shionogi Research Site | São Paulo | São Paulo | 04378-000 | Brazil |
| Shionogi Research Site | Rijeka | Primorje-Gorski Kotar County | 51000 | Croatia |
| Shionogi Research Site | Split | 21000 | Croatia |
| Shionogi Research Site | Zagreb | 10000 | Croatia |
| Shionogi Research Site | La Tronche | Auvergne-Rhône-Alpes | 38043 | France |
| Shionogi Research Site | Paris | Île-de-France Region | 75018 | France |
| Shionogi Research Site | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Shionogi Research Site | Bonn | North Rhine-Westphalia | 53105 | Germany |
| Shionogi Research Site | Berlin | 12351 | Germany |
| Shionogi Research Site | Athens | Attica | 11526 | Greece |
| Shionogi Research Site | Athens | Attica | 12462 | Greece |
| Shionogi Research Site | Patra | Peloponnese | 26504 | Greece |
| Shionogi Research Site | Larissa | Thessaly | 41110 | Greece |
| Shionogi Research Site | Larissa | Thessaly | 41221 | Greece |
| Shionogi Research Site | Guatemala City | Guatemala |
| Shionogi Research Site | Beersheba | Beersheba | 84101 | Israel |
| Shionogi Research Site | Be’er Ya‘aqov | Rehoboth | 70300 | Israel |
| Shionogi Research Site | Tel Aviv | Tel Aviv | 64239 | Israel |
| Shionogi Research Site | Tel Litwinsky | Tel Aviv | 52621 | Israel |
| Shionogi Research Site | Safed | Zefat | 13100 | Israel |
| Shionogi Research Site | Hadera | 38100 | Israel |
| Shionogi Research Site | Haifa | 31048 | Israel |
| Shionogi Research Site | Haifa | 3109601 | Israel |
| Shionogi Research Site | Holon | 58100 | Israel |
| Shionogi Research Site | Jerusalem | 91120 | Israel |
| Shionogi Research Site | Cisanello | PISA | 56124 | Italy |
| Shionogi Research Site | Milan | 20122 | Italy |
| Shionogi Research Site | Milan | 20132 | Italy |
| Shionogi Research Site | Milan | 20162 | Italy |
| Shionogi Research Site | Modena | 41124 | Italy |
| Shionogi Research Site | Udine | 33100 | Italy |
| Shionogi Research Site | Nagakute | Aichi-ken | 480-1195 | Japan |
| Shionogi Research Site | Shinagawa-ku | Tokyo | 142-8999 | Japan |
| Shionogi Research Site | Nagasaki | 852-8501 | Japan |
| Shionogi Research Site | Wŏnju | Gangwon-do | 26426 | South Korea |
| Shionogi Research Site | Seoul | Gwangjin-gu | 5030 | South Korea |
| Shionogi Research Site | Daegu | 41931 | South Korea |
| Shionogi Research Site | Daegu | 41944 | South Korea |
| Shionogi Research Site | Seoul | 06591 | South Korea |
| Shionogi Research Site | Seoul | 06973 | South Korea |
| Shionogi Research Site | Seoul | 07441 | South Korea |
| Shionogi Research Site | Seoul | 135-710 | South Korea |
| Shionogi Research Site | Terrassa | Barcelona | 08035 | Spain |
| Shionogi Research Site | Córdoba | Cordoba | 14004 | Spain |
| Shionogi Research Site | Lleida | Lleida | 25198 | Spain |
| Shionogi Research Site | Barcelona | 08003 | Spain |
| Shionogi Research Site | Barcelona | 08025 | Spain |
| Shionogi Research Site | Barcelona | 08036 | Spain |
| Shionogi Research Site | Ciudad Real | 13005 | Spain |
| Shionogi Research Site | Girona | 17007 | Spain |
| Shionogi Research Site | Madrid | 28046 | Spain |
| Shionogi Research Site | Málaga | 29010 | Spain |
| Shionogi Research Site | Seville | 41009 | Spain |
| Shionogi Research Site | Valencia | 46015 | Spain |
| Shionogi Research Site | Zaragoza | 50009 | Spain |
| Shionogi Research Site | Hualien City | Hualien | 97002 | Taiwan |
| Shionogi Research Site | Taichung | ROC | 40705 | Taiwan |
| Shionogi Research Site | Taipei City | Taipei | 10002 | Taiwan |
| Shionogi Research Site | Kaohsiung City | 81362 | Taiwan |
| Shionogi Research Site | Taichung | 40447 | Taiwan |
| Shionogi Research Site | Bangkok | 10700 | Thailand |
| Shionogi Research Site | Muang Nonthaburi | 11000 | Thailand |
| Shionogi Research Site | Muang | 40002 | Thailand |
| Shionogi Research Site | Bornova | İzmir | 35100 | Turkey (Türkiye) |
| Shionogi Research Site | Ankara | Turkey (Türkiye) |
| Shionogi Research Site | Istanbul | 34098 | Turkey (Türkiye) |
| Shionogi Research Site | Istanbul | 34214 | Turkey (Türkiye) |
| Shionogi Research Site | Trabzon | Turkey (Türkiye) |
| Shionogi Research Site | London | England | SE1 7EH | United Kingdom |
| Shionogi Research Site | London | England | W 120NN | United Kingdom |
| Shionogi Research Site | London | England | W12 0HS | United Kingdom |
| Shionogi Research Site | London | England | United Kingdom |
| 33393598 | Derived | Naseer S, Weinstein EA, Rubin DB, Suvarna K, Wei X, Higgins K, Goodwin A, Jang SH, Iarikov D, Farley J, Nambiar S. US Food and Drug Administration (FDA): Benefit-Risk Considerations for Cefiderocol (Fetroja(R)). Clin Infect Dis. 2021 Jun 15;72(12):e1103-e1111. doi: 10.1093/cid/ciaa1799. |
| 33058795 | Derived | Bassetti M, Echols R, Matsunaga Y, Ariyasu M, Doi Y, Ferrer R, Lodise TP, Naas T, Niki Y, Paterson DL, Portsmouth S, Torre-Cisneros J, Toyoizumi K, Wunderink RG, Nagata TD. Efficacy and safety of cefiderocol or best available therapy for the treatment of serious infections caused by carbapenem-resistant Gram-negative bacteria (CREDIBLE-CR): a randomised, open-label, multicentre, pathogen-focused, descriptive, phase 3 trial. Lancet Infect Dis. 2021 Feb;21(2):226-240. doi: 10.1016/S1473-3099(20)30796-9. Epub 2020 Oct 12. |
| 31819544 | Derived | Bassetti M, Ariyasu M, Binkowitz B, Nagata TD, Echols RM, Matsunaga Y, Toyoizumi K, Doi Y. Designing A Pathogen-Focused Study To Address The High Unmet Medical Need Represented By Carbapenem-Resistant Gram-Negative Pathogens - The International, Multicenter, Randomized, Open-Label, Phase 3 CREDIBLE-CR Study. Infect Drug Resist. 2019 Nov 21;12:3607-3623. doi: 10.2147/IDR.S225553. eCollection 2019. |
| Received Treatment | Safety population |
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| Carbapenem-resistant Microbiological Intent-to-treat | CR Micro-ITT population; See definition in Baseline Characteristics section |
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| COMPLETED |
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| NOT COMPLETED |
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The Carbapenem-resistant Microbiological Intent-to-treat (CR Micro-ITT) population includes randomized participants who received at least 1 dose of study drug and who had a central laboratory confirmed carbapenem resistant Gram-negative pathogen at Baseline from an appropriate clinical biospecimen.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| BG001 | Best Available Therapy (BAT) | Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region | Count of Participants | Participants |
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| Total APACHE II Score | Acute Physiology And Chronic Health Evaluation II is a severity-of-disease classification applied within 24 hours of admission of a patient to an intensive care unit (ICU). The APACHE II score consists of three parts: 12 acute physiological variables, age, and chronic health status. The range of the score is 0 to 71, where higher scores correspond to more severe disease and a higher risk of death. | Count of Participants | Participants |
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| Clinical Diagnosis | BSI = bloodstream infection; cUTI = complicated urinary tract infection; HAP = hospital-acquired pneumonia; HCAP = healthcare-associated pneumonia; VAP = ventilator-associated pneumonia | Count of Participants | Participants |
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| Sequential Organ Failure Assessment (SOFA) Score | The SOFA score is a scoring system to determine the extent of a patient's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each score is from 0 to 4, the total score ranges from 0 to 24, where higher scores indicate a higher likelihood of mortality. | Mean | Standard Deviation | units on a scale |
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| Clinical Pulmonary Infection Score (CPIS) | Clinical pulmonary infection score (CPIS) is a surrogate for diagnosis and treatment response. Points (0, 1, or 2) are assigned for observed findings for 5 variables including body temperature, white blood cell count, tracheal secretions, ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) and chest radiograph infiltrates. The total score ranges from 0 to 10, where higher scores may indicate a higher likelihood of mortality. | Only conducted in participants with HAP/VAP/HCAP; 2 participants had missing CPIS scores at Baseline. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. Participants with missing data were considered as non-responders. | Carbapenem-resistant Microbiological Intent-to-treat (CR Micro-ITT) Population included all participants who received at least 1 dose of the study treatment, who had a baseline Gram-negative pathogen from an appropriate clinical specimen, and whose baseline Gram-negative pathogen was carbapenem-resistant as confirmed by central laboratory testing. | Posted | Number | 95% Confidence Interval | percentage of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Primary | Percentage of Participants With Microbiologic Eradication at TOC in Participants With cUTI | Microbiological outcome per Baseline pathogen was determined by the sponsor as defined for each infection site. For cUTI eradication was defined as a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ colony-forming units (CFU)/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Test of cure, defined as 7 days after the end of treatment, equivalent to Study Days 14 to 21 |
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| Secondary | Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With HAP/VAP/HCAP or BSI/Sepsis | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were counted as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With Sustained Clinical Cure at Follow-up (FU) in Participants With HAP/VAP/HCAP or BSI/Sepsis | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC. BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | Percentage of Participants With Clinical Cure at Test of Cure in Participants With cUTI | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Secondary | Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With cUTI | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered as non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With cUTI | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC. | Carbapenem-resistant Microbiological Intent-to-treat Population); participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | Percentage of Participants With Clinical Cure at End of Treatment in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With Clinical Cure at Test of Cure in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Secondary | Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy is required for the treatment of pneumonia in a participant assessed as cured at TOC. BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy is required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC. cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | Percentage of Participants With Clinical Cure at End of Treatment By Baseline Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis: HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With Clinical Cure at Test of Cure By Baseline Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Secondary | Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC. BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC. cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | Percentage of Participants With Clinical Cure at EOT By Baseline Carbapenem-resistant Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis: HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With Clinical Cure at TOC By Baseline Carbapenem-resistant Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis: HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Secondary | Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Carbapenem-resistant Pathogen | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC. BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC. cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | Percentage of Participants With Microbiologic Eradication at EOT in Participants With HAP/VAP/HCAP or BSI/Sepsis | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria established for each infection site: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With Microbiologic Eradication at TOC in Participants With HAP/VAP/HCAP or BSI/Sepsis | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria established for each infection site: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Secondary | Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With HAP/VAP/HCAP or BSI/Sepsis | Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. If an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. For sepsis, if the participant has a successful clinical outcome after TOC and an appropriate clinical culture could not be obtained, the response was presumed sustained eradication. Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | Percentage of Participants With Microbiologic Eradication at EOT in Participants With cUTI | Microbiological outcome per Baseline pathogen was determined by the sponsor as defined for each infection site. For cUTI eradication was defined as a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With cUTI | Microbiological outcome per Baseline pathogen at follow-up was determined by the sponsor as defined for each infection site. For cUTI sustained eradication was defined as a culture taken any time after documented eradication at TOC and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained <10³ CFU/mL. Overall per-participant sustained eradication was defined as sustained eradication of all Baseline Gram-negative pathogens. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | Percentage of Participants With Microbiologic Eradication at EOT in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With Microbiologic Eradication at TOC in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Secondary | Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. For HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication. cUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained < 10³ CFU/mL. Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | Percentage of Participants With Microbiologic Eradication at EOT By Baseline Pathogen | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant Gram-negative pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With Microbiologic Eradication at TOC By Baseline Pathogen | Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant Gram-negative pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Secondary | Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Pathogen | Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. For HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication. cUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained < 10³ CFU/mL. Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant Gram-negative pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | Percentage of Participants With Microbiologic Eradication at EOT By Baseline Carbapenem-resistant Pathogen | Microbiological outcome per Baseline carbapenem-resistant pathogen were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With Microbiologic Eradication at TOC By Baseline Carbapenem-resistant Pathogen | Microbiological outcome per Baseline carbapenem-resistant pathogen were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication. cUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to < 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Secondary | Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Carbapenem-resistant Pathogen | Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis: HAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. BSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. For HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication. cUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained < 10³ CFU/mL. Overall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC. | Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders. | Posted | Number | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | Percentage of Participants With Microbiologic Eradication at EOT in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia | The percentage of participants who experienced eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture. | Carbapenem-resistant Microbiological Intent-to-treat Population with documented carbapenem-resistant Gram-negative bacteremia at Baseline (all infection sites combined); participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With Microbiologic Eradication at TOC in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia | The percentage of participants who experienced eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture. | Carbapenem-resistant Microbiological Intent-to-treat Population with documented carbapenem-resistant Gram-negative bacteremia at Baseline (all infection sites combined); participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentge of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Secondary | Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia | The percentage of participants who experienced sustained eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture after TOC. | Carbapenem-resistant Microbiological Intent-to-treat Population with documented carbapenem-resistant Gram-negative bacteremia at Baseline (all infection sites combined); participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | Percentage of Participants With a Composite Clinical and Microbiological Response at EOT | The composite clinical and microbiological response rate is defined as the percentage of participants with both clinical cure and microbiologic eradication, as defined above for each site of infection. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, Day 7 to 14 |
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| Secondary | Percentage of Participants With a Composite Clinical and Microbiological Response at TOC | The composite clinical and microbiological response rate is defined as the percentage of participants with both clinical cure and microbiologic eradication, as defined above for each site of infection. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Secondary | Percentage of Participants With a Composite Clinical and Microbiological Response at Follow-up | The composite clinical and microbiological response rate is defined as the percentage of participants with both sustained clinical cure and sustained microbiologic eradication, as defined above for each site of infection. | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 |
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| Secondary | All-cause Mortality at Day 14 and Day 28 | The all-cause mortality rate at Day 14 and Day 28 was calculated as the percentage of participants who experienced mortality regardless of the cause at or before Day 14 and Day 28, respectively. | The safety population includes randomized participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 14 and Day 28 |
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| Secondary | Percentage of Participants Alive and With No Change in Antibiotic Treatment Due to Either Lack of Therapeutic Benefit or Drug-related Toxicity at TOC | Carbapenem-resistant Microbiological Intent-to-treat Population | Posted | Number | 95% Confidence Interval | percentage of participants | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 |
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| Secondary | Survival Time | Survival time was analyzed by Kaplan-Meier survival curve. The table below presents deaths that occurred in10-day time intervals through the end of study | Carbapenem-resistant Microbiological Intent-to-treat Population | Posted | Count of Participants | Participants | Days 1 to 10, 11 to 20, 21 to 30, 31 to 40, 41-50, and 51 to 60. |
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| Secondary | Change From Baseline in Clinical Pulmonary Infection Score (CPIS) in Participants With Pneumonia (HAP/VAP/HCAP) | Clinical pulmonary infection score (CPIS) is a surrogate for diagnosis and treatment response. Points (0, 1, or 2) are assigned for observed findings for 5 variables including body temperature, white blood cell count, tracheal secretions, ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), and chest radiograph infiltrates. The total score ranges from 0 to 10, where higher scores may indicate a higher likelihood of mortality; a negative change from Baseline indicates improvement | Carbapenem-resistant microbiological intention-to-treat population; Participants with pneumonia and CPIS measurement at Baseline and at each post-baseline time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, end of treatment (Day 7-14), test of cure (7 days after end of treatment, equivalent to Study Day 14 to 21) and follow-up (14 days after end of treatment, equivalent to Study Day 21 to 28) |
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| Secondary | Change From Baseline in Sequential Organ Failure Assessment (SOFA) | The SOFA score is a scoring system to determine the extent of a patient's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each score is from 0 to 4, and the total score ranges from 0 to 24, where higher scores indicate a higher likelihood of mortality. A negative change from Baseline score indicates improvement. | Carbapenem-resistant microbiological intention-to-treat population with SOFA measurement at Baseline and at each post-baseline time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, end of treatment (Day 7 to 14), test of cure (7 days after end of treatment, equivalent to Study Day 14 to 21) and follow-up (14 days after end of treatment, equivalent to Study Day 21 to 28) |
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| Secondary | Number of Participants With Adverse Events | The severity of each adverse event (AE) was graded by the investigator according to the following definitions:
The relationship of AEs to study treatment was determined by the investigator according to the following definition: ● Related: An AE which can be reasonably explained as having been caused by the study treatment. A serious AE is defined as any AE that resulted in any of the following outcomes:
| Safety population | Posted | Count of Participants | Participants | From first dose of study drug up to 28 days after last dose; maximum treatment duration was 29 days in the cefiderocol group and 22 days in the BAT group. |
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From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. | 34 | 101 | 50 | 101 | 88 | 101 |
| EG001 | Best Available Therapy (BAT) | Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. | 9 | 49 | 23 | 49 | 43 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
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| Pulseless electrical activity | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA version 18.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA version 18.1 | Systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA version 18.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 18.1 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA version 18.1 | Systematic Assessment |
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| Chronic hepatic failure | Hepatobiliary disorders | MedDRA version 18.1 | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA version 18.1 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA version 18.1 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Empyema | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Endocarditis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Enterococcal bacteraemia | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Osteomyelitis acute | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Quadriplegia | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Pupils unequal | Eye disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Catheter site inflammation | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Gallbladder necrosis | Hepatobiliary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Acinetobacter infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Candiduria | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Corynebacterium infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Wound infection pseudomonas | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 18.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 18.1 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA version 18.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA version 18.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Gastrointestinal stoma output increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| White blood cell count abnormal | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Cerebral small vessel ischaemic disease | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Bladder disorder | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Renal tubular acidosis | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Genital erythema | Reproductive system and breast disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Oedema genital | Reproductive system and breast disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
|
The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shionogi Clinical Trials Administrator | Shionogi Inc. | 800-849-9707 | shionogiclintrials-admin@shionogi.co.jp |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 16, 2017 | Oct 20, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D018805 | Sepsis |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
Not provided
Not provided
| ID | Term |
|---|---|
| D000097602 | Cefiderocol |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | Overall: Cefiderocol | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | Overall: Best Available Therapy | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy |
Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | Overall: Cefiderocol | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | Overall: Best Available Therapy | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | Overall: Cefiderocol | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | Overall: Best Available Therapy | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| HAP/VAP/HCAP: Best Available Therapy |
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| HAP/VAP/HCAP: Best Available Therapy |
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | Overall: Cefiderocol | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | Overall: Best Available Therapy | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy |
Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | Overall: Cefiderocol | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | Overall: Best Available Therapy | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy |
Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | Overall: Cefiderocol | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | Overall: Best Available Therapy | Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| HAP/VAP/HCAP: Best Available Therapy |
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| HAP/VAP/HCAP: Best Available Therapy |
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| HAP/VAP/HCAP: Best Available Therapy |
Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
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| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
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| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
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| BSI/Sepsis: Best Available Therapy |
Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol | Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy | Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG008 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG009 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
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| OG002 | BSI/Sepsis: Cefiderocol | Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG003 | BSI/Sepsis: Best Available Therapy | Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG004 | cUTI: Cefiderocol | Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG005 | cUTI: Best Available Therapy | Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
| OG006 | Overall: Cefiderocol | Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days. |
| OG007 | Overall: Best Available Therapy | Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. |
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