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

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00136201

Purpose

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	Intervention	Phase
Abdominal Abscess	Drug: tigecycline	Phase III

MedlinePlus related topics: Antibiotics

Drug Information available for: Tigecycline Cilastatin Cilastatin sodium Imipenem

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Wyeth:

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

Estimated Enrollment:	200
Study Start Date:	November 2005
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136201

Locations

China

Shanghai, China, 200040

Shanghai, China, 200433

Beijing, China, 100044

Beijing, China, 100730

Shanghai, China, 200001

Wuhan, China, 300063

Beijing, China, 100853

Shanghai, China, 200092
China, Chengdu

Guoxuexiang, Chengdu, China, 610041
China, LiaoNing

Shengyang, LiaoNing, China, 110001
China, Zhejiang

Hangzhou, Zhejiang, China

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For China, medinfo@wyeth.com

More Information

Study ID Numbers:	3074A1-316
Study First Received:	August 25, 2005
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00136201
Health Authority:	China: State Food and Drug Administration

Keywords provided by Wyeth:

Peritonitis
Community-Acquired Infections
Cross Infection

Study placed in the following topic categories:

Abdominal Abscess
Tigecycline
Cilastatin
Peritonitis
Abscess

Community-Acquired Infections
Suppuration
Cross Infection
Imipenem

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009