Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

The secondary objective is to evaluate the safety and efficacy of tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful.

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

Details

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

Criteria

Inclusion Criteria:

• Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms.

• Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies.

• Patient must give informed consent.

Exclusion Criteria:

• Patients with an expected survival of less than 2 weeks.

• Patients who have been designated as "Do Not Resuscitate".

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

• Pregnant women or nursing mothers.