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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 - Article


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Azithromycin

Zithromax 




Clinical Trial: 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.

Sponsored by: Pfizer
Information provided by: AIDS Clinical Trials Information Service

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 Treatment or Intervention
Mycobacterium avium-intracellulare Infection
HIV Infections
Tuberculosis, Mycobacterium Infection
 Drug: Azithromycin

MedlinePlus related topics:  AIDS;   Bacterial Infections;   Tuberculosis

Study Type: Interventional
Study Design: Treatment, Safety Study

Eligibility

Genders Eligible for Study:  Both

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.

Location Information


Connecticut
      Pfizer Central Research, Groton,  Connecticut,  06340,  United States

Maryland
      Natl Cancer Institute / Metabolism Branch, Bethesda,  Maryland,  20892,  United States

More Information

Study ID Numbers:  058D; 066-169
Record last reviewed:  July 1998
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002085
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: June 1, 2005
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