| September 12, 2005 |
| April 16, 2009 |
| September 2005 |
| February 2008 (final data collection date for primary outcome measure) |
| Clinical Response in the Clinically Evaluable Population at the Test-of-Cure Visit. [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ] |
| Clinical response in the clinically evaluable population at the Test-of-Cure visit. |
| Complete list of historical versions of study NCT00195351 on ClinicalTrials.gov Archive Site |
- Clinical Response in the Microbiologically Evaluable Population [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ]
- Microbiological Response (Eradication Rate at the Subject Level) [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ]
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- 1. Clinical Response in the microbiologically evaluable population.
- 2. Microbiological Response at the subject and pathogen levels.
- 3. Overall Response defined as a combination of the Clinical Response and the Microbiological Response at the subject level.
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| |
| Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-Abdominal Infection |
| 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 phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10. 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). |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
- Appendicitis
- Cholecystitis
- Cross Infection
- Diverticulitis
- Peritonitis
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- Drug: tigecycline
- Drug: ceftriaxone sodium + metronidazole
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| |
| |
| |
| Completed |
| 467 |
| February 2008 |
| February 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
- Fever over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain.
Exclusion Criteria:
- Cancer
- Medicines that suppress the immune system
- Dialysis
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Argentina, Brazil, Canada, Chile, Mexico |
| |
| NCT00195351 |
| Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| 3074A1-400 |
| Wyeth |
|
| Study Director: |
Medical Monitor |
Wyeth |
|
|
| Wyeth |
| April 2009 |