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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection; HIV Infections; Tuberculosis, Mycobacterium Infection
Intervention: Azithromycin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer
Summary
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.
Clinical Details
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
Study design: Treatment, Safety Study
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
Pfizer Central Research, Groton, Connecticut 06340, United States
Natl Cancer Institute / Metabolism Branch, Bethesda, Maryland 20892, United States
Additional Information
Last updated: June 23, 2005
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