A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy

Pfizer

Status: Completed

Conditions: Tuberculosis, Mycobacterium Infection; Mycobacterium Avium-Intracellulare Infection; HIV Infections

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002085

058D

066-169

Details and patient eligibility

About

To evaluate the efficacy and safety of azithromycin given chronically for the treatment of serious nontuberculous mycobacterial infection in patients failing or intolerant of other available therapy.

Sex: All

Ages: 1+ day old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Other antimicrobial drugs as long as documented on Case Report Form.

Patients must have:

• Serious nontuberculous mycobacterial infection.
• Approval of eligibility from Pfizer Clinical Monitor. Patients below the legal age of consent must have consent of parent or guardian.

NOTE:

• Pregnant women, women of childbearing potential, and children will not be specifically excluded from participation. However, patients and physicians should be aware that the safety of azithromycin during pregnancy and in long-term use in children and adults has not been established. The risks and benefits of azithromycin use in these patients will be considered in consultation with the physician and the Pfizer Clinical Monitor.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Disseminated Mycobacterium avium complex (MAC) who are eligible for treatment with azithromycin under protocol 066-162.
• Known hypersensitivity or intolerance to macrolide antibiotics.

Patients with the following prior conditions are excluded:

History of hypersensitivity or intolerance to azithromycin.