A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Cilastatin; Imipenem; Minocycline; Tigecycline

Criteria

Inclusion Criteria:

• Hospitalized male or female subjects, at least 18 year of age.

• Complicated intra-abdominal infection is present at most under two weeks duration.

• Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly suspected intra-abdominal infection.

Exclusion Criteria:

• Anticipated length of antibiotic therapy less than 5 days or the likelihood that the subject will not complete the course of treatment.

• Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not susceptible to both of the study drugs.

• Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment except for subjects declared prior failures.