Clinical Trial: Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Open-Label Comparison of the Safety and Efficacy of Tigecycline> vs Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Chinese Subjects

Brief Summary: The primary objective of this study is to compare the safety and efficacy of an experimental antibiotic to a marketed antibiotic in the treatment of Chinese subjects with complicated intra-abdominal infections. <br />

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit

Original Primary Outcome: Clinical response for all microbiologically evaluable and microbiological modified intent-to-treat subjects at the test-of-cure visit.

Current Secondary Outcome: Microbiological response at the subject and pathogen level and evaluation of microbiological data, such as decreased susceptibility, response rates by baseline isolate and minimal inhibitory concentration (MIC) values and susceptibility data by isolate

Original Secondary Outcome: Microbiological response at the subject and pathogen level & evaluation of microbiological data, such as decreased susceptibility, response rates by baseline isolate and MIC values and susceptibility data by isolate

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: August 25, 2005
Date Started: November 2005
Date Completion:
Last Updated: July 6, 2009
Last Verified: July 2009