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

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 />

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Key information

Conditions

Abdominal Abscess Abscess Community-Acquired Infections Cross Infection Digestive System Diseases Disease Attributes Iatrogenic Disease Infections Intraabdominal Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritonitis Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Guoxuexiang, Chengdu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tigecycline

Drug

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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Aug 26, 2005
Registry last updated: Jul 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed