Clinical Trial: Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections
Brief Summary: This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with meropenem in the treatment of complicated intra-abdominal infections (cIAIs).
Detailed Summary:
Sponsor: Tetraphase Pharmaceuticals, Inc.
Current Primary Outcome: Number of Participants with a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population [ Time Frame: TOC visit: 25-31 days after first dose of study drug ]
Original Primary Outcome: Number of participants with a favorable clinical response at the test-of-cure (TOC) visit for those participants with at least one baseline pathogen [ Time Frame: TOC visit: 25-31 days after the initial dose ]
Current Secondary Outcome:
- Number of Participants with a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population [ Time Frame: TOC visit: 25-31 days after first dose of study drug ]
- Number of Participants with a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population [ Time Frame: TOC visit: 25-31 days after first dose of study drug ]
Original Secondary Outcome:
Information By: Tetraphase Pharmaceuticals, Inc.
Dates:
Date Received: May 23, 2016
Date Started: October 2016
Date Completion: December 2017
Last Updated: March 17, 2017
Last Verified: March 2017
