Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections
NCT00136201
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· Hospitalized male or female subjects over 18 years of age
· 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.
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Descriptive Information | |||||||
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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 * |
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* 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 | 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 |
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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 |
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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 |