Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
NCT00230971
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- Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
- Fever plus other symptoms such as nausea, vomiting, abdominal pain.
- Cancer
- Medicines that suppress the immune system
- Dialysis
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Descriptive Information | |||||||||||||||||||||||||||||||||||||
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Brief Title ICMJE | Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) | ||||||||||||||||||||||||||||||||||||
Official Title ICMJE | A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection | ||||||||||||||||||||||||||||||||||||
Brief Summary | This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s). | ||||||||||||||||||||||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||||||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||||||
Study Phase ICMJE | Phase 4 | ||||||||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||||||||||||||||||||||||||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg Infect (Larchmt). 2012 Apr;13(2):102-9. doi: 10.1089/sur.2011.048. Epub 2012 Mar 22. | ||||||||||||||||||||||||||||||||||||
* 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 | ||||||||||||||||||||||||||||||||||||
Actual Enrollment ICMJE | 473 | ||||||||||||||||||||||||||||||||||||
Original Enrollment ICMJE | 430 | ||||||||||||||||||||||||||||||||||||
Actual Study Completion Date ICMJE | September 2008 | ||||||||||||||||||||||||||||||||||||
Actual Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | Australia, China, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom | ||||||||||||||||||||||||||||||||||||
Removed Location Countries | Czech Republic | ||||||||||||||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT00230971 | ||||||||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | 3074A1-315 | ||||||||||||||||||||||||||||||||||||
Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||||||||||||||
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 | February 2013 | ||||||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |