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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7625A-014 | Other Identifier | Merck Registration Number | |
| 163276 | Registry Identifier | JAPIC-CTI |
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This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) for the treatment of complicated urinary tract infection (cUTI) including pyelonephritis (uncomplicated or complicated pyelonephritis and complicated lower urinary tract infection) in Japanese participants. Efficacy will be primarily assessed by microbiological response defined as eradication of the baseline pathogen or pathogens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-7625A | Experimental | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion every 8 hours for 7 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) | Drug | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC) | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at TOC (14 days post first dose). Microbiological outcome was classified as "eradication", "persistence" or "indeterminate." A successful microbiological response was "eradication" which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was" persistence" (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as "indeterminate" were excluded. | Day 14 (14 days post first dose of study drug) |
| Percentage of Participants Who Report 1 or More Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized. | Up to 42 days post first dose of study drug |
| Percentage of Participants Discontinuing Study Drug Due to an AE | An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not considered related to the medicinal product. The percentage of participants that had study drug discontinued during the study due to an AE was summarized. | Up to 7 days after the first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Microbiological Response of Eradication at End Of Therapy (EOT) | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at EOT (7 days post first dose of study drug). Microbiological outcome was classified as "eradication", "persistence" or "indeterminate." A successful microbiological response was "eradication" which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was" persistence" (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as "indeterminate" were excluded. |
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Inclusion Criteria:
Japanese males or females who need hospitalization
Clinical signs and/or symptoms of urinary tract infection (UTI) at screening visit, either one of the following:
Has a pretreatment baseline urine culture specimen obtained within 24 hours of start of study drug
Requires IV antibacterial therapy for the treatment of the presumed UTI
Female participants of child bearing potential must not be pregnant (negative human chorionic gonadotropin test) or breastfeeding and must agree to use adequate contraception for the duration of the study and up to 35 days after the last dose of study drug
Male participants must agree to use adequate contraception for the duration of the study and up to 75 days after the last dose of study drug
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30420153 | Background | Arakawa S, Kawahara K, Kawahara M, Yasuda M, Fujimoto G, Sato A, Yokokawa R, Yoshinari T, Rhee EG, Aoyama N. The efficacy and safety of tazobactam/ceftolozane in Japanese patients with uncomplicated pyelonephritis and complicated urinary tract infection. J Infect Chemother. 2019 Feb;25(2):104-110. doi: 10.1016/j.jiac.2018.10.009. Epub 2018 Nov 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-7625A | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion every 8 hours for 7 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2015 |
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| Day 7 (7 days post first dose of study drug) |
| Percentage of Participants With Microbiological Response of Eradication at Late Follow-up (LFU) | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at LFU (42 days post first dose of study drug). Microbiological outcome was classified as "eradication", "persistence" or "indeterminate." A successful microbiological response was "eradication" which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was" persistence" (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as "indeterminate" were excluded. | Day 42 (42 days post first dose of study drug) |
| Percentage of Participants With Clinical Response of Clinical Cure at TOC | The Investigator classified clinical outcome as "clinical cure", "clinical failure", or "indeterminate". A favorable clinical response is "clinical cure" defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as "indeterminate" were excluded. Percentage of participants with clinical response of clinical cure at TOC was summarized | Day 14 (14 days post first dose of study drug) |
| Percentage of Participants With Clinical Response of Clinical Cure at EOT | The Investigator classified clinical outcome as "clinical cure", "clinical failure", or "indeterminate". A favorable clinical response is "clinical cure" defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as "indeterminate" were excluded. Percentage of participants with clinical response of clinical cure at EOT was summarized | Day 7 (7 days post first dose of study drug) |
| Percentage of Participants With Clinical Response of Clinical Cure at LFU | The Investigator classified clinical outcome as "clinical cure", "clinical failure", or "indeterminate". A favorable clinical response is "clinical cure" defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as "indeterminate" were excluded. Percentage of participants with clinical response of clinical cure at LFU was summarized. | Day 42 (42 days post first dose of study drug) |
| Percentage of Participants With a Composite Response of Both Eradication and Clinical Cure at TOC | The percentage of participants that met requirements for both eradication and clinical cure at TOC was summarized. | Day 14 (14 days post first dose of study drug) |
| Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as "Eradication", "Persistence" or "Indeterminate." A successful microbiological response was "Eradication" which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as a failure. Outcomes reported as "indeterminate" were excluded. The percentage of participants that achieved eradication for each uropathogen at EOT (7 days post first dose of study drug) was summarized. | Day 7 (7 days post first dose of study drug) |
| Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as "Eradication", "Persistence" or "Indeterminate." A successful microbiological response was "Eradication" which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced), the result was classified as a failure. Outcomes reported as "indeterminate" were excluded. The percentage of participants that achieved eradication for each uropathogen at TOC (14 days post first dose of study drug) was summarized. | Day 14 (14 days post first dose of study drug) |
| Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as "Eradication", "Persistence" or "Indeterminate." A successful microbiological response was "Eradication" which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as a failure. Outcomes reported as "indeterminate" were excluded. The percentage of participants that achieved eradication for each uropathogen LFU (42 days post first dose of study drug) was summarized. . | Day 42 (42 days post first dose of study drug) |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-7625A | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion every 8 hours for 7 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC) | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at TOC (14 days post first dose). Microbiological outcome was classified as "eradication", "persistence" or "indeterminate." A successful microbiological response was "eradication" which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was" persistence" (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as "indeterminate" were excluded. | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 14 (14 days post first dose of study drug) |
|
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| Primary | Percentage of Participants Who Report 1 or More Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized. | All participants who received at least 1 dose of study treatment and had follow-up data for endpoint. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 42 days post first dose of study drug |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants Discontinuing Study Drug Due to an AE | An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not considered related to the medicinal product. The percentage of participants that had study drug discontinued during the study due to an AE was summarized. | All participants who received at least 1 dose of study treatment and had follow-up data for endpoint. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 7 days after the first dose of study drug |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Microbiological Response of Eradication at End Of Therapy (EOT) | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at EOT (7 days post first dose of study drug). Microbiological outcome was classified as "eradication", "persistence" or "indeterminate." A successful microbiological response was "eradication" which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was" persistence" (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as "indeterminate" were excluded. | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 7 (7 days post first dose of study drug) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Microbiological Response of Eradication at Late Follow-up (LFU) | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at LFU (42 days post first dose of study drug). Microbiological outcome was classified as "eradication", "persistence" or "indeterminate." A successful microbiological response was "eradication" which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was" persistence" (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as "indeterminate" were excluded. | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 42 (42 days post first dose of study drug) |
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| Secondary | Percentage of Participants With Clinical Response of Clinical Cure at TOC | The Investigator classified clinical outcome as "clinical cure", "clinical failure", or "indeterminate". A favorable clinical response is "clinical cure" defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as "indeterminate" were excluded. Percentage of participants with clinical response of clinical cure at TOC was summarized | All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 14 (14 days post first dose of study drug) |
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| Secondary | Percentage of Participants With Clinical Response of Clinical Cure at EOT | The Investigator classified clinical outcome as "clinical cure", "clinical failure", or "indeterminate". A favorable clinical response is "clinical cure" defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as "indeterminate" were excluded. Percentage of participants with clinical response of clinical cure at EOT was summarized | All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 7 (7 days post first dose of study drug) |
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| Secondary | Percentage of Participants With Clinical Response of Clinical Cure at LFU | The Investigator classified clinical outcome as "clinical cure", "clinical failure", or "indeterminate". A favorable clinical response is "clinical cure" defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as "indeterminate" were excluded. Percentage of participants with clinical response of clinical cure at LFU was summarized. | All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 42 (42 days post first dose of study drug) |
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| Secondary | Percentage of Participants With a Composite Response of Both Eradication and Clinical Cure at TOC | The percentage of participants that met requirements for both eradication and clinical cure at TOC was summarized. | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 14 (14 days post first dose of study drug) |
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| Secondary | Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as "Eradication", "Persistence" or "Indeterminate." A successful microbiological response was "Eradication" which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as a failure. Outcomes reported as "indeterminate" were excluded. The percentage of participants that achieved eradication for each uropathogen at EOT (7 days post first dose of study drug) was summarized. | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 7 (7 days post first dose of study drug) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as "Eradication", "Persistence" or "Indeterminate." A successful microbiological response was "Eradication" which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced), the result was classified as a failure. Outcomes reported as "indeterminate" were excluded. The percentage of participants that achieved eradication for each uropathogen at TOC (14 days post first dose of study drug) was summarized. | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 14 (14 days post first dose of study drug) |
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| Secondary | Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU | The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as "Eradication", "Persistence" or "Indeterminate." A successful microbiological response was "Eradication" which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as a failure. Outcomes reported as "indeterminate" were excluded. The percentage of participants that achieved eradication for each uropathogen LFU (42 days post first dose of study drug) was summarized. . | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 42 (42 days post first dose of study drug) |
|
up to 35 post last dose of study drug (up to 42 days total)
All participants that received at least 1 dose of study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-7625A | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion every 8 hours for 7 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min. | 0 | 114 | 13 | 114 | 26 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pyelonephritis chronic | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Patella fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Aug 20, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D011704 | Pyelonephritis |
| 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 |
| D009395 | Nephritis, Interstitial |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D011702 | Pyelitis |
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Not provided
| ID | Term |
|---|---|
| C519491 | ceftolozane |
| D000078142 | Tazobactam |
| ID | Term |
|---|---|
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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