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This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types (Hospital Acquired Pneumonia [HAP] (including Ventilator-Associated Pneumonia [VAP]); Complicated Urinary-Tract Infection [cUTI]; Complicated Intra-Abdominal Infection [cIAI]; Bloodstream Infection [BSI]) due to carbapenem-resistant Gram-negative pathogens in China.This study will be an estimation study. The statistical inference will be based on point estimate and confidence interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAZ-AVI | Experimental | ceftazidime 2g plus avibactam 0.5g |
|
| Best Available Treatment | Active Comparator | Based on investigative site practice and local epidemiology and guideline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zavicefta, Ceftazidime-Avibactam | Drug | CAZ-AVI 2.5 g (2 g ceftazidime + 0.5 g avibactam) administered IV as a 2 hour infusion every 8 hours. Dose adjustments are available for participants with CrCL ≤50 mL/min. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit - Microbiologically Modified Intent-to-Treat (mMITT) Analysis Set | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e, complicated intra-abdominal infection [cIAI], complicated urinary-tract infection [cUTI], hospital-acquired pneumonia/ventilator-associated pneumonia [HAP/VAP] or bloodstream infection [BSI]) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95 percent (%) confidence interval (CI) was calculated using Jeffrey's method. | At TOC visit (From Day 21 up to Day 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Cure at TOC Visit - Microbiologically Evaluable (ME) Analysis Set | Clinical cure: improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for index infection (i.e. cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since initial procedure. 95% CI based on Jeffrey's method. ME analysis set (sub-set of mMITT): participants who received 3 days of study intervention, or received study intervention for >=48 hours with >= 80% compliance, or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms genetically confirmed by central microbiological testing, no indeterminate clinical outcome at end of treatment (EOT) or TOC visits, no important protocol deviations that affect assessment of efficacy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical | Bengbu | Anhui | 233000 | China | ||
| The First Affiliated Hospital of Bengbu Medical College |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 64 participants were screened of which 3 participants failed screening and 1 participant was not randomized in the study. A total of 60 participants were enrolled and randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftazidime-Avibactam | Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received Ceftazidime-Avibactam (CAZ-AVI) 2.5 grams (g) (2 g ceftazidime + 0.5 g avibactam) administered intravenously (IV) as 2-hour infusion every 8 hours (q8h) for 14 days. |
| FG001 |
| 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2022 | Aug 1, 2024 |
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| Best Available Treatment | Drug | main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem |
|
| At TOC visit (From Day 21 up to Day 24) |
| Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit -mMITT Analysis Set | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95% CI was calculated using Jeffrey's method. | At EOT visit (up to 24 hours after the last infusion on Day 14) |
| Percentage of Participants With Clinical Cure at EOT Visit - ME Analysis Set | Clinical cure: improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since initial procedure. 95% CI based on Jeffrey's method. ME analysis set (sub-set of mMITT): participants who received 3 days of study intervention, or received study intervention for >=48 hours with >= 80% compliance, or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms genetically confirmed by central microbiological testing, no indeterminate clinical outcome at EOT or TOC visits, no important protocol deviations that affect assessment of efficacy. | At EOT visit (up to 24 hours after the last infusion on Day 14) |
| Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - mMITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 colony forming units per milliliter [CFU/mL] for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/ clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method. | At TOC visit (From Day 21 up to Day 24) |
| Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - ME Analysis Set | Favorable microbiological response=eradication: absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from appropriately obtained specimen at site of infection or presumed eradication: repeat culture of specimens were not performed/clinically indicated in participant who had clinical cure (specific to cIAI,HAP/VAP participants). 95% CI was calculated using Jeffrey's method. ME analysis set: participants received 3 days of study intervention,or received study intervention for >= 48 hours with >=80% compliance or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing, no indeterminate clinical outcome at EOT/TOC, no important protocol deviations that affect assessment of efficacy. | At TOC visit (From Day 21 up to Day 24) |
| Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - mMITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method. | At EOT visit (Up to 24 hours after last infusion on Day 14) |
| Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - ME Analysis Set | Favorable microbiological response=eradication: absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from appropriately obtained specimen at site of infection or presumed eradication: repeat culture of specimens were not performed/clinically indicated in participant who had clinical cure (specific to cIAI,HAP/VAP participants). 95% CI was calculated using Jeffrey's method. ME analysis set: participants received 3 days of study intervention,or received study intervention for >= 48 hours with >=80% compliance or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing, no indeterminate clinical outcome at EOT/TOC, no important protocol deviations that affect assessment of efficacy. | At EOT visit (Up to 24 hours after last infusion on Day 14) |
| Percentage of Participants With Favorable Per-Pathogen Microbiological Response at TOC Visit - mMITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method. | At TOC visit (From Day 21 up to Day 24) |
| Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT Visit - mMITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method. | At EOT visit (Up to 24 hours after last infusion on Day 14) |
| Percentage of Participants Who Died Due to Any Cause Until Day 28 | Percentage of participants who died due to any cause up to Day 28 was reported in this outcome measure. The 95% CI was calculated using the Jeffrey's method. | From first dose of study intervention (Day 1) up to Day 28 |
| Number of Participants With Treatment-Emergent Adverse Events | An adverse event (AE) was any untoward medical occurrence in a study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse event (TEAE) was any AE that started after the study intervention start date and time. | From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days) |
| Number of Participants With Discontinuation Due to Adverse Events | Number of participants who discontinued the study due to adverse events were reported in this outcome measure. Discontinuations from study due to TEAEs included all participants with an AE record indicating that the AE caused permanent discontinuation from the study. Permanent discontinuations from any study intervention due to TEAEs included participants with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. | From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days) |
| Number of Participants With Potentially Clinically Significant Post-baseline Hematology Values | Potentially clinically significant hematology parameters included Hemoglobin (gram/deciliter), Hematocrit (%), Erythrocytes (10^12/Liter [L]): value < 0.8*lower limit of normal (LLN) and change (Chg) > 20% decrease, value > 1.3*upper limit of normal (ULN) and Chg > 30% increase. Platelets (10^9/L): Value < 0.65*LLN and Chg > 50% decrease, Value > 1.5*ULN and Chg > 100% increase. Leukocytes (10^9/L): Value < 0.65*LLN and Chg > 60% decrease, Value > 1.6*ULN and Chg > 100% increase. Lymphocytes (10^9/L): Value < 0.25*LLN and Chg > 75% decrease, Value > 1.5*ULN and Chg > 100% increase. Neutrophils (10^9/L): Value < 0.65*LLN and Chg > 75% decrease, Value > 1.6*ULN and Chg > 100% increase. Basophils (10^9/L), Eosinophils (10^9/L), Monocytes (10^9/L): Value > 4.0*ULN and Chg > 300% increase. Number of participants with potentially clinically significant values for any hematology parameters were reported in this outcome measure. | From first dose of study treatment (Day 1) until TOC (Up to Day 24) |
| Number of Participants With Potentially Clinically Significant Post-baseline Clinical Chemistry Values | Potentially clinically significant criteria included Bilirubin(mg/dL): >2.0*ULN and Chg >150% increase (inc).Aspartate Aminotransferase,Alanine Aminotransferase(Units/Liter[U/L]):>3.0*ULN and Chg >200% inc.Alkaline Phosphatase(U/L):<0.5*LLN and Chg >80% decrease (dec),> 2.0*ULN and Chg >100% inc.Protein,Albumin(g/dL):<0.5*LLN and Chg >50% dec,>1.5*ULN and Chg >50% inc.Blood Urea Nitrogen(mg/dL):<0.2*LLN and Chg >100% dec, >3.0*ULN and Chg >200% inc.Creatinine(mg/dL):>2.0*ULN and Chg >100% inc.Sodium(milliequivalent[mEq]/L):<0.85*LLN and Chg >10% dec, >1.1*ULN and Chg >10% inc.Potassium,Chloride(mEq/L):<0.8*LLN and Chg >20% dec, >1.2*ULN and Chg >20% inc.Calcium(mg/dL):<0.7*LLN and Chg >30% dec,> 1.3*ULN and Chg >30% inc.Bicarbonate(mEq/L):<0.7*LLN and Chg >40% dec, >1.3*ULN and Chg >40% inc.Glucose(mg/dL):<0.6*LLN and Chg >40% dec, >3.0*ULN and Chg >200% inc.Number of participants with potentially clinically significant values for any clinical chemistry parameters were reported. | From first dose of study treatment (Day 1) until TOC (Up to Day 24) |
| Bengbu |
| Anhui |
| 233004 |
| China |
| Chizhou People's Hospital | Chizhou | Anhui | 247000 | China |
| Fuyang People's Hospital | Fuyang | Anhui | 236000 | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Zhongshan Hospital Xiamen University | Xiamen | Fujian | 361004 | China |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | 510180 | China |
| Qingyuan People's Hospital | Qingyuan | Guangdong | 511518 | China |
| Shenzhen People's Hospital | Shenzhen | Guangdong | 518020 | China |
| The Second People's Hospital of Shenzhen | Shenzhen | Guangdong | 518035 | China |
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | 524000 | China |
| Affiliated Hospital of Guilin Medical College | Guilin | Guangxi | 541001 | China |
| Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | 563000 | China |
| Affiliated Hospital of Hebei University | Baoding | Hebei | 071000 | China |
| Luoyang Central Hospital | Luoyang | Henan | 471009 | China |
| NanYang central hospital | Nanyang | Henan | 473000 | China |
| Henan provincial people's hospital | Zhengzhou | Henan | 450000 | China |
| Henan provincial people's hospital | Zhengzhou | Henan | 450003 | China |
| Baotou Central Hospital | Baotou | Inner Mongolia | 014000 | China |
| Jiangyin People's Hospital | Jiangyin | Jiangsu | 214400 | China |
| Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221006 | China |
| Subei People's Hospital of Jiangsu province | Yangzhou | Jiangsu | 225001 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Chengdu Xinhua Hospital | Chengdu | Sichuan | 610055 | China |
| Tianjin Chest Hospital | Tianjin | Tianjin Municipality | 300222 | China |
| The First People's Hospital of Kunming (South Hospital) | Kunming | Yunnan | 650034 | China |
| The First people's Hospital of Kunming | Kunming | Yunnan | 650034 | China |
| The First People's Hospital of Kunming Ganmei Hospital (North Hospital) | Kunming | Yunnan | 650224 | China |
| Zhejiang Hospital | Hangzhou | Zhejiang | 310013 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310014 | China |
| Lishui People's Hospital | Lishui | Zhejiang | 323000 | China |
| Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang | 317000 | China |
| The 2nd Affiliated Hospital of WMU | Wenzhou | Zhejiang | 325035 | China |
| Wenzhou Central Hospital | Wenzhou | Zhejiang | 325099 | China |
| Jiangyin People's Hospital | Jiangyin | 214400 | China |
| Shanghai Fifth People's Hospital, Fudan University | Shanghai | 200240 | China |
| Best Available Treatment |
Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received best available treatment (BAT) based on investigative site practice and local epidemiology and guideline for 14 days. |
| Safety Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all participants who took any study intervention. Participants were analyzed according to the product they actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ceftazidime-Avibactam | Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received CAZ-AVI 2.5 g (2 g ceftazidime + 0.5 g avibactam) administered IV as 2-hour infusion q8h for 14 days. |
| BG001 | Best Available Treatment | Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received BAT based on investigative site practice and local epidemiology and guideline for 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, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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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) Visit - Microbiologically Modified Intent-to-Treat (mMITT) Analysis Set | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e, complicated intra-abdominal infection [cIAI], complicated urinary-tract infection [cUTI], hospital-acquired pneumonia/ventilator-associated pneumonia [HAP/VAP] or bloodstream infection [BSI]) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95 percent (%) confidence interval (CI) was calculated using Jeffrey's method. | mMITT analysis set (subset of ITT analysis set) included all participants who met minimum disease requirements and received any amount of study therapy, had at least 1 carbapenem-resistant Gram-negative pathogen in an adequate initial/pre-study culture. Participants with inherently resistant pathogens (monomicrobial infections due to any Acinetobacter species) were excluded from mMITT analysis set. | Posted | Number | 95% Confidence Interval | Percentage of participants | At TOC visit (From Day 21 up to Day 24) |
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| Secondary | Percentage of Participants With Clinical Cure at TOC Visit - Microbiologically Evaluable (ME) Analysis Set | Clinical cure: improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for index infection (i.e. cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since initial procedure. 95% CI based on Jeffrey's method. ME analysis set (sub-set of mMITT): participants who received 3 days of study intervention, or received study intervention for >=48 hours with >= 80% compliance, or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms genetically confirmed by central microbiological testing, no indeterminate clinical outcome at end of treatment (EOT) or TOC visits, no important protocol deviations that affect assessment of efficacy. | ME analysis set was evaluated. | Posted | Number | 95% Confidence Interval | Percentage of participants | At TOC visit (From Day 21 up to Day 24) |
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| Secondary | Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit -mMITT Analysis Set | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response was assessed by the independent adjudication committee. 95% CI was calculated using Jeffrey's method. | mMITT analysis set (subset of ITT analysis set) included all participants who met minimum disease requirements and received any amount of study therapy, had at least 1 carbapenem-resistant Gram-negative pathogen in an adequate initial/pre-study culture. Participants with inherently resistant pathogens (monomicrobial infections due to any Acinetobacter species) were excluded from the mMITT analysis set. | Posted | Number | 95% Confidence Interval | Percentage of participants | At EOT visit (up to 24 hours after the last infusion on Day 14) |
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| Secondary | Percentage of Participants With Clinical Cure at EOT Visit - ME Analysis Set | Clinical cure: improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since initial procedure. 95% CI based on Jeffrey's method. ME analysis set (sub-set of mMITT): participants who received 3 days of study intervention, or received study intervention for >=48 hours with >= 80% compliance, or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms genetically confirmed by central microbiological testing, no indeterminate clinical outcome at EOT or TOC visits, no important protocol deviations that affect assessment of efficacy. | ME analysis set was evaluated. | Posted | Number | 95% Confidence Interval | Percentage of participants | At EOT visit (up to 24 hours after the last infusion on Day 14) |
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| Secondary | Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - mMITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 colony forming units per milliliter [CFU/mL] for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/ clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method. | mMITT analysis set (subset of ITT analysis set) included all participants who met minimum disease requirements and received any amount of study therapy, had at least 1 carbapenem-resistant Gram-negative pathogen in an adequate initial/pre-study culture. Participants with inherently resistant pathogens (monomicrobial infections due to any Acinetobacter species) were excluded from the mMITT analysis set. | Posted | Number | 95% Confidence Interval | Percentage of participants | At TOC visit (From Day 21 up to Day 24) |
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| Secondary | Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit - ME Analysis Set | Favorable microbiological response=eradication: absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from appropriately obtained specimen at site of infection or presumed eradication: repeat culture of specimens were not performed/clinically indicated in participant who had clinical cure (specific to cIAI,HAP/VAP participants). 95% CI was calculated using Jeffrey's method. ME analysis set: participants received 3 days of study intervention,or received study intervention for >= 48 hours with >=80% compliance or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing, no indeterminate clinical outcome at EOT/TOC, no important protocol deviations that affect assessment of efficacy. | ME analysis set was evaluated. | Posted | Number | 95% Confidence Interval | Percentage of participants | At TOC visit (From Day 21 up to Day 24) |
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| Secondary | Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - mMITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method. | mMITT analysis set (subset of ITT analysis set) included all participants who met minimum disease requirements and received any amount of study therapy, had at least 1 carbapenem-resistant Gram-negative pathogen in an adequate initial/pre-study culture. Participants with inherently resistant pathogens (monomicrobial infections due to any Acinetobacter species) were excluded from the mMITT analysis set. | Posted | Number | 95% Confidence Interval | Percentage of participants | At EOT visit (Up to 24 hours after last infusion on Day 14) |
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| Secondary | Percentage of Participants With Favorable Per-Participant Microbiological Response at EOT Visit - ME Analysis Set | Favorable microbiological response=eradication: absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from appropriately obtained specimen at site of infection or presumed eradication: repeat culture of specimens were not performed/clinically indicated in participant who had clinical cure (specific to cIAI,HAP/VAP participants). 95% CI was calculated using Jeffrey's method. ME analysis set: participants received 3 days of study intervention,or received study intervention for >= 48 hours with >=80% compliance or for <48 hours before discontinuation due to adverse event, no concomitant antibiotics against baseline carbapenem-resistant gram negative pathogens between first dose and TOC (excluding participants with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing, no indeterminate clinical outcome at EOT/TOC, no important protocol deviations that affect assessment of efficacy. | ME analysis set was evaluated. | Posted | Number | 95% Confidence Interval | Percentage of participants | At EOT visit (Up to 24 hours after last infusion on Day 14) |
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| Secondary | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at TOC Visit - mMITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method. | mMITT analysis set: all participants who met minimum disease requirements, received any amount of study therapy, had at least 1 carbapenem-resistant Gram-negative pathogen in an adequate initial/pre-study culture. Participants with inherently resistant pathogens were excluded. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. 'Number Analyzed' =number of participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of participants | At TOC visit (From Day 21 up to Day 24) |
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| Secondary | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT Visit - mMITT Analysis Set | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification <10^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). 95% CI was calculated using Jeffrey's method. | mMITT analysis set: all participants who met minimum disease requirements, received any amount of study therapy, had at least 1 carbapenem-resistant Gram-negative pathogen in an adequate initial/pre-study culture. Participants with inherently resistant pathogens were excluded. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. 'Number Analyzed' =number of participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of participants | At EOT visit (Up to 24 hours after last infusion on Day 14) |
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| Secondary | Percentage of Participants Who Died Due to Any Cause Until Day 28 | Percentage of participants who died due to any cause up to Day 28 was reported in this outcome measure. The 95% CI was calculated using the Jeffrey's method. | Intent-to-Treat (ITT) Analysis Set included all participants randomly assigned to study intervention and who took at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose of study intervention (Day 1) up to Day 28 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events | An adverse event (AE) was any untoward medical occurrence in a study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse event (TEAE) was any AE that started after the study intervention start date and time. | Safety analysis set included all participants who took any study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days) |
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| Secondary | Number of Participants With Discontinuation Due to Adverse Events | Number of participants who discontinued the study due to adverse events were reported in this outcome measure. Discontinuations from study due to TEAEs included all participants with an AE record indicating that the AE caused permanent discontinuation from the study. Permanent discontinuations from any study intervention due to TEAEs included participants with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. | Safety analysis set included all participants who took any study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 up to 32 days after the last dose of study intervention (Up to 46 days) |
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| Secondary | Number of Participants With Potentially Clinically Significant Post-baseline Hematology Values | Potentially clinically significant hematology parameters included Hemoglobin (gram/deciliter), Hematocrit (%), Erythrocytes (10^12/Liter [L]): value < 0.8*lower limit of normal (LLN) and change (Chg) > 20% decrease, value > 1.3*upper limit of normal (ULN) and Chg > 30% increase. Platelets (10^9/L): Value < 0.65*LLN and Chg > 50% decrease, Value > 1.5*ULN and Chg > 100% increase. Leukocytes (10^9/L): Value < 0.65*LLN and Chg > 60% decrease, Value > 1.6*ULN and Chg > 100% increase. Lymphocytes (10^9/L): Value < 0.25*LLN and Chg > 75% decrease, Value > 1.5*ULN and Chg > 100% increase. Neutrophils (10^9/L): Value < 0.65*LLN and Chg > 75% decrease, Value > 1.6*ULN and Chg > 100% increase. Basophils (10^9/L), Eosinophils (10^9/L), Monocytes (10^9/L): Value > 4.0*ULN and Chg > 300% increase. Number of participants with potentially clinically significant values for any hematology parameters were reported in this outcome measure. | Safety analysis set included all participants who took any study intervention. Participants were analyzed according to the product they actually received. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) until TOC (Up to Day 24) |
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| Secondary | Number of Participants With Potentially Clinically Significant Post-baseline Clinical Chemistry Values | Potentially clinically significant criteria included Bilirubin(mg/dL): >2.0*ULN and Chg >150% increase (inc).Aspartate Aminotransferase,Alanine Aminotransferase(Units/Liter[U/L]):>3.0*ULN and Chg >200% inc.Alkaline Phosphatase(U/L):<0.5*LLN and Chg >80% decrease (dec),> 2.0*ULN and Chg >100% inc.Protein,Albumin(g/dL):<0.5*LLN and Chg >50% dec,>1.5*ULN and Chg >50% inc.Blood Urea Nitrogen(mg/dL):<0.2*LLN and Chg >100% dec, >3.0*ULN and Chg >200% inc.Creatinine(mg/dL):>2.0*ULN and Chg >100% inc.Sodium(milliequivalent[mEq]/L):<0.85*LLN and Chg >10% dec, >1.1*ULN and Chg >10% inc.Potassium,Chloride(mEq/L):<0.8*LLN and Chg >20% dec, >1.2*ULN and Chg >20% inc.Calcium(mg/dL):<0.7*LLN and Chg >30% dec,> 1.3*ULN and Chg >30% inc.Bicarbonate(mEq/L):<0.7*LLN and Chg >40% dec, >1.3*ULN and Chg >40% inc.Glucose(mg/dL):<0.6*LLN and Chg >40% dec, >3.0*ULN and Chg >200% inc.Number of participants with potentially clinically significant values for any clinical chemistry parameters were reported. | Safety analysis set included all participants who took any study intervention. Participants were analyzed according to the product they actually received. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) until TOC (Up to Day 24) |
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From start of study intervention on Day 1 up to 32 days after the last dose of study intervention (up to 46 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. All-cause mortality was assessed in ITT analysis set and SAEs and non-SAEs were assessed in safety population.
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 | Ceftazidime-Avibactam | Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received CAZ-AVI 2.5 g (2 g ceftazidime + 0.5 g avibactam) administered IV as 2-hour infusion q8h for 14 days. | 6 | 30 | 7 | 30 | 17 | 30 |
| EG001 | Best Available Treatment | Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received BAT based on investigative site practice and local epidemiology and guideline for 14 days. | 9 | 29 | 11 | 29 | 18 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Acid base balance abnormal | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2023 | Aug 1, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D000077299 | Healthcare-Associated Pneumonia |
| D053717 | Pneumonia, Ventilator-Associated |
| D016470 | Bacteremia |
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003428 | Cross Infection |
| 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 |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
Not provided
Not provided
| ID | Term |
|---|---|
| C000595613 | avibactam, ceftazidime drug combination |
Not provided
Not provided
Not provided
| 45-64 years |
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| Greater than equal to (>=) 65 years |
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Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received BAT based on investigative site practice and local epidemiology and guideline for 14 days. |
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Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received BAT based on investigative site practice and local epidemiology and guideline for 14 days.
|
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Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received BAT based on investigative site practice and local epidemiology and guideline for 14 days.
|
|
Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received BAT based on investigative site practice and local epidemiology and guideline for 14 days. |
|
|
|
|
Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received BAT based on investigative site practice and local epidemiology and guideline for 14 days. |
|
|
Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received BAT based on investigative site practice and local epidemiology and guideline for 14 days. |
|
|
Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received BAT based on investigative site practice and local epidemiology and guideline for 14 days. |
|
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| OG001 | Best Available Treatment | Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received BAT based on investigative site practice and local epidemiology and guideline for 14 days. |
|
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| OG001 | Best Available Treatment | Participants with confirmed carbapenem-resistant Gram-negative pathogens infection received BAT based on investigative site practice and local epidemiology and guideline for 14 days. |
|
|