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).
- 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
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | |||||||||||||||||||||||||||||||||||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
