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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites200 target enrollmentNovember 2005

ConditionsAbdominal Abscess

Interventionstigecycline

Drugstigecycline

Overview

Phase: Phase 3
Intervention: tigecycline
Conditions: Abdominal Abscess
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 200
Primary Endpoint: Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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 />

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

December 2006

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

Inclusion Criteria

•· Hospitalized male or female subjects over 18 years of age

Exclusion Criteria

•· Subjects with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed.

Arms & Interventions

1

armDesc1

Intervention: tigecycline

Outcomes

Primary Outcomes

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

Secondary Outcomes

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