Status:
COMPLETED
A Study of Standard Drugs for Mycobacterium Avium Complex
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
American College of Chest Physicians
Conditions:
Mycobacterium Avium Complex
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
To assess the early bactericidal activity of Azithromycin 250mg by mouth daily over the first 14 days of treatment for Mycobacterium avium complex (MAC) lung disease.
Detailed Description
This research is being done to better understand several important aspects of treatment of Mycobacterium avium complex (MAC) lung infections using an early bactericidal activity (EBA) study design. MA...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Isolation of M. avium intracellulare complex from a respiratory specimen in the preceding 6 months
- Fulfill American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA) criteria for MAC lung disease
- Intention by the treating clinician to treat for MAC lung disease.
- Ability to produce a sputum sample of at least 10mL in a 16 hour period
- Signed informed consent by the subject
Exclusion
- Prior treatment for pulmonary MAC within the past 6 months
- Pregnancy
- HIV with a cluster of differentiation 4 (CD4) \<350
- History of solid organ or hematologic transplant
- Contraindication to azithromycin
- Has any other condition that, in the opinion of the PI, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04287049
Start Date
February 24 2020
End Date
March 21 2025
Last Update
November 17 2025
Active Locations (1)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205