Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abdominal Abscess
Intervention: tigecycline (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer Trial Manager, Principal Investigator, Affiliation: For China, medinfo@wyeth.com
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Beijing 100044, China
Beijing 100730, China
Beijing 100853, China
Shanghai 200001, China
Shanghai 200040, China
Shanghai 200092, China
Shanghai 200433, China
Wuhan 300063, China
Guoxuexiang, Chengdu 610041, China
Shengyang, Liaoning 110001, China
Hangzhou, Zhejiang, China
Additional Information
Starting date: November 2005
Last updated: July 6, 2009
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