Phase 3
N=115
Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014)
Urinary Tract Infection (UTI) · Complicated Urinary Tract Infection · Pyelonephritis · Uncomplicated Pyelonephritis
Bottom Line
View on ClinicalTrials.gov: NCT02728089 ↗Enrolled (actual)
115
Serious AEs
11.4%
Results posted
Sep 2018
Primary outcome: Primary: Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC) — 80.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC) |
80.7 | — |
| PRIMARY Percentage of Participants Who Report 1 or More Adverse Event (AE) |
58.8 | — |
| PRIMARY Percentage of Participants Discontinuing Study Drug Due to an AE |
1.8 | — |
| SECONDARY Percentage of Participants With Microbiological Response of Eradication at End Of Therapy (EOT) |
100.0 | — |
| SECONDARY Percentage of Participants With Microbiological Response of Eradication at Late Follow-up (LFU) |
61.0 | — |
| SECONDARY Percentage of Participants With Clinical Response of Clinical Cure at TOC |
96.6 | — |
| SECONDARY Percentage of Participants With Clinical Response of Clinical Cure at EOT |
97.8 | — |
| SECONDARY Percentage of Participants With Clinical Response of Clinical Cure at LFU |
78.2 | — |
| SECONDARY Percentage of Participants With a Composite Response of Both Eradication and Clinical Cure at TOC |
80.7 | — |
| SECONDARY Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC |
100.0; 100.0; 82.9; 42.9; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU |
100.0; 100.0; 62.9; 37.5; 66.7; 100.0 | — |
Summary
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.
Eligibility Criteria
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:
- Pyelonephritis (uncomplicated or complicated)
- Complicated lower UTI (cUTI)
- 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
- Has a history of recent or recurrent Gram-positive organism UTI suggesting colonization, or participant with UTI that shows or suspects the presence of a Gram-positive organism only
- Has a history of any moderate or severe hypersensitivity or allergic reaction to any Beta-lactam antibacterial including cephalosporins, carbapenems and penicillins, or tazobactam
- Has a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to study drug with the exception of an antibacterial with Gram-positive activity only (vancomycin, linezolid, daptomycin and teicoplanin)
- Is receiving probenecid
- Is currently receiving bladder infusions with topical urinary antiseptics or antibacterial agents
- Has received any amount of potentially therapeutic antibacterial therapy after collection of the pretreatment baseline urine culture and before administration of the first dose of study drug.
- Has received any dose of a potentially therapeutic antibacterial agent for the treatment of the current UTI within 48 hours before the pretreatment baseline urine is obtained
- Intractable urinary infection at baseline that would require more than 7 days of study drug
- Has complete, permanent obstruction of the urinary tract.
- Has confirmed fungal urinary tract infection at time of randomization (with ≥ 10^3 fungal colony forming units /mL)
- Has permanent indwelling bladder catheter or urinary stent including nephrostomy
- Has suspected or confirmed perinephric or intrarenal abscess
- Has suspected or confirmed prostatitis, urethritis, or epididymitis
- Has ileal loop or known vesico-ureteral reflux
- Severe impairment of renal function including an estimated CrCl 14 days prior to study start
- Has participated in any clinical study of an investigational product within 30 days prior to the first dose of study drug
- Has previously participated in any study of ceftolozane or MK-7625A.
Data sourced from ClinicalTrials.gov (NCT02728089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.