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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Pfizer
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002085

Purpose

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.

Condition	Intervention
Mycobacterium Avium-Intracellulare Infection HIV Infections Tuberculosis, Mycobacterium Infection	Drug: Azithromycin

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Mycobacterial Infections Tuberculosis

Drug Information available for: Azithromycin

U.S. FDA Resources

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002085

Locations

United States, Connecticut
Pfizer Central Research
Groton, Connecticut, United States, 06340
United States, Maryland
Natl Cancer Institute / Metabolism Branch
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

Pfizer

More Information

No publications provided

Study ID Numbers:	058D, 066-169
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002085 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
Azithromycin
Mycobacterium Infections, Atypical

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Infection
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Azithromycin
Therapeutic Uses
Tuberculosis
Retroviridae Infections
RNA Virus Infections

Immune System Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Actinomycetales Infections
Mycobacterium Infections, Atypical
Pharmacologic Actions
Mycobacterium avium-intracellulare Infection
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on February 08, 2010