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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Cross Infection; Gram-Positive Bacterial Infections

Treatments: Drug: Tigecycline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00081744

3074A1-301

Details and patient eligibility

About

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

Enrollment: 850 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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