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
Overview
- Phase
- Phase 4
- Intervention
- tigecycline
- Conditions
- Appendicitis
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 467
- Primary Endpoint
- Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
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
- •Medicines that suppress the immune system
Arms & Interventions
A
Intervention: tigecycline
B
Intervention: ceftriaxone sodium + metronidazole
Outcomes
Primary Outcomes
Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.
Time Frame: 10-21 days after the last dose of test article
The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.
Secondary Outcomes
- Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.(10-21 days after the last dose of test article)
- Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.(10-21 days after the last dose of test article)