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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

Last updated on March 14, 2019

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Study Location
Pfizer Central Research
Groton, Connecticut, 06340 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mycobacterium Avium-Intracellulare Infection, HIV Infections, Mycobacterium Infection Tuberculosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT00002085
Pfizer
Completed
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

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[email protected]

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