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Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014)

NCT02728089 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2019-02-05

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-14
Primary Completion
2017-09-05
Completion
2017-09-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02728089 on ClinicalTrials.gov