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

Phase 3

Completed

• Conditions: Gram-Positive Bacterial Infections; Cross Infection

• Registration Number: NCT00081744
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2004-04-19
• Study First Submitted QC: 2004-04-20
• Study First Posted: 2004-04-21
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 850

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified