Trials / Completed
CompletedNCT02728089
Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014)
A Multicenter, Open-label, Noncomparative, Japanese Phase III Study to Assess the Efficacy and Safety of Ceftolozane/Tazobactam (MK-7625A) in Japanese Patients With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Urinary Tract Infection (UTI)
- Complicated Urinary Tract Infection
- Pyelonephritis
- Uncomplicated Pyelonephritis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion |
Timeline
- Start date
- 2016-04-14
- Primary completion
- 2017-09-05
- Completion
- 2017-09-05
- First posted
- 2016-04-05
- Last updated
- 2019-02-05
- Results posted
- 2018-09-19
Source: ClinicalTrials.gov record NCT02728089. Inclusion in this directory is not an endorsement.