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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

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 plus other symptoms such as nausea, vomiting, abdominal pain.

Exclusion Criteria:

• Cancer

• Medicines that suppress the immune system

• Dialysis