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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Co

Brief 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.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at Test of Cure (TOC) [ Time Frame: up to 14 days after the first dose of study drug (up to 14 days) ]
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: From time of first dose of study drug until the end of follow-up (up to 42 days) ]
  • Percentage of Participants Discontinuing Study Drug Due to AEs [ Time Frame: up to 7 days after the first dose of study drug (up to 7 days) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at End Of Therapy (EOT) and Late Follow-up (LFU) [ Time Frame: up to 42 days after first dose of study drug (up to 42 days) ]
  • Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC, EOT, and LFU [ Time Frame: up to 42 days after first dose of study drug (up to 42 days) ]
  • Percentage of Participants With a Composite Response of Both Microbiological Response (Eradication, Persistence, or Indeterminate) and Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC [ Time Frame: up to 14 days after the first dose of study drug (up to 14 days) ]
  • Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at EOT, TOC, and LFU [ Time Frame: up to 42 days after first dose of study drug (up to 42 days) ]


Original Secondary Outcome: Same as current

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: March 30, 2016
Date Started: April 14, 2016
Date Completion: August 22, 2017
Last Updated: May 17, 2017
Last Verified: May 2017