| Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) |
| 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 |
| 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). |
| Not Provided |
| Interventional |
| Phase 4 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment |
- Appendicitis
- Cholecystitis
- Diverticulitis
- Intra-Abdominal Abscess
- Intra-Abdominal Infection
- Peritonitis
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- Drug: tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
- Drug: ceftriaxone plus metronidazole
Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
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| 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. |
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| Completed |
| 473 |
| September 2008 |
| September 2008 (Final data collection date for primary outcome measure) |
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Inclusion Criteria:
- Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
- Fever plus other symptoms such as nausea, vomiting, abdominal pain.
Exclusion Criteria:
- Cancer
- Medicines that suppress the immune system
- Dialysis
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| Sexes Eligible for Study: |
All |
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| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Australia, China, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom |
| Czech Republic |
| |
| NCT00230971 |
| 3074A1-315 |
| Not Provided |
| Not Provided |
| Not Provided |
| Wyeth is now a wholly owned subsidiary of Pfizer |
| Wyeth is now a wholly owned subsidiary of Pfizer |
| Not Provided |
| Study Director: |
Medical Monitor |
Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: |
Trial Manager |
For Australia, China, Hong Kong, [email protected]
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| Principal Investigator: |
Trial Manager |
For Taiwan, [email protected]
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| Principal Investigator: |
Trial Manager |
For Denmark, Finland, [email protected]
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| Principal Investigator: |
Trial Manager |
For Germany, [email protected]
|
| Principal Investigator: |
Trial Manager |
For South Africa, [email protected]
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| Principal Investigator: |
Trial Manager |
For Italy, Greece, [email protected]
|
| Principal Investigator: |
Trial Manager |
For UK, [email protected]
|
| Principal Investigator: |
Trial Manager |
For Switzerland, [email protected]
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| Principal Investigator: |
Trial Manager |
For France, [email protected]
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| Principal Investigator: |
Trial Manager |
For Spain, [email protected]
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| Principal Investigator: |
Trial Manager |
For Turkey, [email protected]
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| Wyeth is now a wholly owned subsidiary of Pfizer |
| February 2013 |
