Overview

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection

Status:
Completed

Trial end date:
2008-02-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Treatments:

Ceftriaxone
Metronidazole
Minocycline
Tigecycline

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:

- Cancer

- Medicines that suppress the immune system

- Dialysis