Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Cilastatin; Imipenem; Minocycline; Tigecycline

Criteria

Inclusion Criteria:

• Male or female subjects, ≥ 8 years of age and a weight of ≥ 35 kilograms

• Subjects with selected culture-positive infections caused by a multiple antibiotic-resistant pathogen presumed to be susceptible to tigecycline

• Subjects who have failed or are intolerant of other available appropriate antibiotic therapies or whose pathogens are resistant to other available antibiotics

Exclusion Criteria:

• Subjects who are moribund with an expected survival of less than 2 weeks.

• Subjects who have been designated as "Do Not Resuscitate", unless it is anticipated within a reasonable degree of medical certainty that they can achieve benefit from potentially curative antibiotic therapy

• Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents