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

Wyeth

Status and phase

Completed

Phase 3

Conditions

Bacterial Infections

Treatments

Drug: Tigecycline

Study type

Interventional

Funder types

Industry

Identifiers

NCT00205816

3074A1-310

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

8+ years old

Volunteers

No Healthy Volunteers

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.