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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00136201
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : July 7, 2009
Sponsor:
Information provided by:

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

Study Type : Interventional  (Clinical Trial)
Estimated 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
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
armDesc1
Drug: tigecycline


Outcome Measures

Primary Outcome Measures :
  1. Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit

Secondary Outcome Measures :
  1. 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, Senior)
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
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
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):
ClinicalTrials.gov Identifier: NCT00136201     History of Changes
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:
Infection
Intraabdominal Infections
Abdominal Abscess
Abscess
Suppuration
Imipenem
Tigecycline
Minocycline
Cilastatin
Anti-Bacterial Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action