Trial Outcomes & Findings for Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014) (NCT NCT02728089)
NCT ID: NCT02728089
Last Updated: 2019-02-05
Results Overview
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.
COMPLETED
PHASE3
115 participants
Day 14 (14 days post first dose of study drug)
2019-02-05
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
115
|
|
Overall Study
Treated
|
114
|
|
Overall Study
COMPLETED
|
112
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014)
Baseline characteristics by cohort
| Measure |
MK-7625A
n=115 Participants
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.
|
|---|---|
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Age, Continuous
|
68.2 Years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
115 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14 (14 days post first dose of study drug)Population: 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.
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.
Outcome measures
| Measure |
MK-7625A
n=88 Participants
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.
|
|---|---|
|
Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC)
|
80.7 Percentage of participants
Interval 70.9 to 88.3
|
PRIMARY outcome
Timeframe: Up to 42 days post first dose of study drugPopulation: All participants who received at least 1 dose of study treatment and had follow-up data for endpoint.
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.
Outcome measures
| Measure |
MK-7625A
n=114 Participants
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.
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|---|---|
|
Percentage of Participants Who Report 1 or More Adverse Event (AE)
|
58.8 Percentage of participants
Interval 49.2 to 67.9
|
PRIMARY outcome
Timeframe: Up to 7 days after the first dose of study drugPopulation: All participants who received at least 1 dose of study treatment and had follow-up data for endpoint.
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.
Outcome measures
| Measure |
MK-7625A
n=114 Participants
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.
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|---|---|
|
Percentage of Participants Discontinuing Study Drug Due to an AE
|
1.8 Percentage of participants
Interval 0.2 to 6.2
|
SECONDARY outcome
Timeframe: Day 7 (7 days post first dose of study drug)Population: 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.
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.
Outcome measures
| Measure |
MK-7625A
n=87 Participants
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.
|
|---|---|
|
Percentage of Participants With Microbiological Response of Eradication at End Of Therapy (EOT)
|
100.0 Percentage of participants
Interval 95.8 to 100.0
|
SECONDARY outcome
Timeframe: Day 42 (42 days post first dose of study drug)Population: 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.
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.
Outcome measures
| Measure |
MK-7625A
n=82 Participants
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.
|
|---|---|
|
Percentage of Participants With Microbiological Response of Eradication at Late Follow-up (LFU)
|
61.0 Percentage of participants
Interval 49.6 to 71.6
|
SECONDARY outcome
Timeframe: Day 14 (14 days post first dose of study drug)Population: 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.
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
Outcome measures
| Measure |
MK-7625A
n=89 Participants
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.
|
|---|---|
|
Percentage of Participants With Clinical Response of Clinical Cure at TOC
|
96.6 Percentage of participants
Interval 90.5 to 99.3
|
SECONDARY outcome
Timeframe: Day 7 (7 days post first dose of study drug)Population: 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.
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
Outcome measures
| Measure |
MK-7625A
n=89 Participants
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.
|
|---|---|
|
Percentage of Participants With Clinical Response of Clinical Cure at EOT
|
97.8 Percentage of participants
Interval 92.1 to 99.7
|
SECONDARY outcome
Timeframe: Day 42 (42 days post first dose of study drug)Population: 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.
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.
Outcome measures
| Measure |
MK-7625A
n=87 Participants
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.
|
|---|---|
|
Percentage of Participants With Clinical Response of Clinical Cure at LFU
|
78.2 Percentage of participants
Interval 68.0 to 86.3
|
SECONDARY outcome
Timeframe: Day 14 (14 days post first dose of study drug)Population: 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.
The percentage of participants that met requirements for both eradication and clinical cure at TOC was summarized.
Outcome measures
| Measure |
MK-7625A
n=88 Participants
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.
|
|---|---|
|
Percentage of Participants With a Composite Response of Both Eradication and Clinical Cure at TOC
|
80.7 Percentage of participants
Interval 70.9 to 88.3
|
SECONDARY outcome
Timeframe: Day 7 (7 days post first dose of study drug)Population: 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.
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.
Outcome measures
| Measure |
MK-7625A
n=87 Participants
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.
|
|---|---|
|
Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT
Proteus mirabilis
|
100.0 Percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT
Enterobacter aerogenes
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT
Escherichia coli
|
100.0 Percentage of participants
Interval 95.3 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT
Klebsiella pneumoniae
|
100.0 Percentage of participants
Interval 59.0 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT
Proteus vulgaris
|
100.0 Percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT
Pseudomonas aeruginosa
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: Day 14 (14 days post first dose of study drug)Population: 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.
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.
Outcome measures
| Measure |
MK-7625A
n=88 Participants
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.
|
|---|---|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC
Citrobacter koseri
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC
Enterobacter aerogenes
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC
Escherichia coli
|
82.9 Percentage of participants
Interval 72.5 to 90.6
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC
Klebsiella pneumoniae
|
42.9 Percentage of participants
Interval 9.9 to 81.6
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC
Proteus mirabilis
|
100.0 Percentage of participants
Interval 29.2 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC
Proteus vulgaris
|
100.0 Percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC
Pseudomonas aeruginosa
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: Day 42 (42 days post first dose of study drug)Population: 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.
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. .
Outcome measures
| Measure |
MK-7625A
n=82 Participants
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.
|
|---|---|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU
Citrobacter koseri
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU
Enterobacter aerogenes
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU
Escherichia coli
|
62.9 Percentage of participants
Interval 50.5 to 74.1
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU
Klebsiella pneumoniae
|
37.5 Percentage of participants
Interval 8.5 to 75.5
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU
Proteus mirabilis
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU
Proteus vulgaris
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU
Pseudomonas aeruginosa
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
Adverse Events
MK-7625A
Serious adverse events
| Measure |
MK-7625A
n=114 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
0.88%
1/114 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Gastritis
|
0.88%
1/114 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Ileus
|
0.88%
1/114 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.88%
1/114 • Number of events 1 • 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
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.88%
1/114 • Number of events 1 • 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
|
|
Infections and infestations
Pneumonia bacterial
|
0.88%
1/114 • Number of events 1 • 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
|
|
Infections and infestations
Pyelonephritis
|
0.88%
1/114 • Number of events 1 • 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
|
|
Infections and infestations
Pyelonephritis acute
|
2.6%
3/114 • Number of events 3 • 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
|
|
Infections and infestations
Pyelonephritis chronic
|
0.88%
1/114 • Number of events 1 • 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
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.88%
1/114 • Number of events 1 • 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
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.88%
1/114 • Number of events 1 • 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
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.88%
1/114 • Number of events 1 • 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
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.88%
1/114 • Number of events 1 • 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
|
Other adverse events
| Measure |
MK-7625A
n=114 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
7.9%
9/114 • Number of events 9 • 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
|
|
Gastrointestinal disorders
Diarrhoea
|
7.9%
9/114 • Number of events 9 • 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
|
|
Investigations
Alanine aminotransferase increased
|
7.9%
9/114 • Number of events 9 • 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
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
7/114 • Number of events 7 • 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
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER