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

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ClinicalTrials.gov Identifier: NCT00136201

Recruitment Status : Completed

First Posted : August 26, 2005

Last Update Posted : July 7, 2009

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

Study Description

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 />

Condition or disease	Intervention/treatment	Phase
Abdominal Abscess	Drug: tigecycline	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	November 2005
Actual Primary Completion Date :	December 2006
Actual Study Completion Date :	December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Drug Information available for: Tigecycline

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 armDesc1	Drug: tigecycline

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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 Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136201

Locations

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China, Chengdu

Guoxuexiang, Chengdu, China, 610041
China, Liaoning

Shengyang, Liaoning, China, 110001
China, Zhejiang

Hangzhou, Zhejiang, China
China

Beijing, China, 100044

Beijing, China, 100730

Beijing, China, 100853

Shanghai, China, 200001

Shanghai, China, 200040

Shanghai, China, 200092

Shanghai, China, 200433

Wuhan, China, 300063

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

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Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trial Manager	For China, medinfo@wyeth.com

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen Z, Wu J, Zhang Y, Wei J, Leng X, Bi J, Li R, Yan L, Quan Z, Chen X, Yu Y, Wu Z, Liu D, Ma X, Maroko R, Cooper A. Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial. BMC Infect Dis. 2010 Jul 21;10:217. doi: 10.1186/1471-2334-10-217.

Fomin P, Koalov S, Cooper A, Babinchak T, Dartois N, De Vane N, Castaing N, Tellado J; 301 And 306 Study Groups. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections - the European experience. J Chemother. 2008 Oct;20 Suppl 1:12-9.

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ClinicalTrials.gov Identifier:	NCT00136201
Other Study ID Numbers:	3074A1-316
First Posted:	August 26, 2005 Key Record Dates
Last Update Posted:	July 7, 2009
Last Verified:	July 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:


Peritonitis Community-Acquired Infections Cross Infection

Additional relevant MeSH terms:

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Infection Intraabdominal Infections Abdominal Abscess Abscess Suppuration Tigecycline	Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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