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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Mycobacterium Avium-Intracellulare Infection HIV Infections Tuberculosis, Mycobacterium Infection

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Azithromycin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Pfizer Central Research

Groton, Connecticut, United States

Site Status

Natl Cancer Institute / Metabolism Branch

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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066-169

Identifier Type: -

Identifier Source: secondary_id

058D