Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections
NCT00136201
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Adult Trials: 18+ Years
· 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 | |||||||
|---|---|---|---|---|---|---|---|
| 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 | 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 |
| ||||||
| 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 |
| ||||||
| 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 | |||||||