Clinical Trial: A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Double-blind, Randomized, Comparison Study Of The Efficacy And Safety Of Tigecycline To Imipenem/Cilastatin To Treat Complicated Intra-abdominal Infections
Brief Summary: This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: Number of Participants with Clinical Response at Test-of-Cure (TOC) Visit [ Time Frame: 14-21 days after last dose of therapy ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical response at the test-of-cure assessment for the microbiologically evaluable (ME) population [ Time Frame: 14-21 days after last dose of therapy ]
- Microbiological response by baseline isolate for the ME and m-mITT populations [ Time Frame: 14-21 days after last dose of therapy ]
Original Secondary Outcome: Same as current
Information By: Pfizer
Dates:
Date Received: October 31, 2012
Date Started: November 2012
Date Completion:
Last Updated: March 22, 2016
Last Verified: March 2016
