Early Bactericidal Activity of Standard Drugs Used to Treat Mycobacterium Avium Complex: a Pilot Study
Who is this study for? Patients with mycobacterium avium complex
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
United States
Maryland
Johns Hopkins University School of Medicine
Baltimore
Time Frame
Start Date: 2020-02-24
Completion Date: 2025-03-21
Participants
Target number of participants: 10
Treatments
Experimental: 14 Day Azithromycin Monotherapy
For the first 14 days of therapy, participants will receive Azithromycin 250mg PO daily as monotherapy. Beyond day 14, all participants will receive guideline-based standard multi-drug therapy for Mycobacterium avium lung disease, as dictated by the physicians treating the participants.
Authors
Kelly Dooley, Keira A Cohen
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), American College of Chest Physicians
Leads: Johns Hopkins University