A Study of Standard Drugs for Mycobacterium Avium Complex

• Status: Recruiting
• Trial end date: 2022-05-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.