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Trial record 1 of 1 for:    NCT00136201
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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

Tracking Information
First Submitted Date  ICMJE August 25, 2005
First Posted Date  ICMJE August 26, 2005
Last Update Posted Date July 7, 2009
Study Start Date  ICMJE November 2005
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2005)
Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
Clinical response for all microbiologically evaluable and microbiological modified intent-to-treat subjects at the test-of-cure visit.
Change History Complete list of historical versions of study NCT00136201 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2005)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
Microbiological response at the subject and pathogen level & evaluation of microbiological data, such as decreased susceptibility, response rates by baseline isolate and MIC values and susceptibility data by isolate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections
Official Title  ICMJE 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
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 />
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Abdominal Abscess
Intervention  ICMJE Drug: tigecycline
Study Arms  ICMJE Experimental: 1
armDesc1
Intervention: Drug: tigecycline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 25, 2005)
200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136201
Other Study ID Numbers  ICMJE 3074A1-316
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For China, medinfo@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP