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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


N/A
N/A
N/A
Not Enrolling
Both
Mycobacterium Avium-Intracellulare Infection, HIV Infections, Tuberculosis, Mycobacterium Infection

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

058D

NCT ID:

NCT00002085

Start Date:

Completion Date:

Related Keywords:

  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
  • Tuberculosis, Mycobacterium Infection
  • Mycobacterium avium-intracellulare Infection
  • Acquired Immunodeficiency Syndrome
  • Azithromycin
  • Mycobacterium Infections, Atypical
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Mycobacterium Infections
  • Mycobacterium avium-intracellulare Infection
  • Tuberculosis

Name

Location

Pfizer Central ResearchGroton, Connecticut  06340
Natl Cancer Institute / Metabolism BranchBethesda, Maryland  20892