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

July 6, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
      • Beijing, China, 100730
      • Beijing, China, 100853
      • Shanghai, China, 200040
      • Shanghai, China, 200001
      • Shanghai, China, 200433
      • Shanghai, China, 200092
      • Wuhan, China, 300063
    • Chengdu
      • Guoxuexiang, Chengdu, China, 610041
    • Liaoning
      • Shengyang, Liaoning, China, 110001
    • Zhejiang
      • Hangzhou, Zhejiang, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
armDesc1
Drug: tigecycline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

July 7, 2009

Last Update Submitted That Met QC Criteria

July 6, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3074A1-316

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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