Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
Status:
Recruiting
Trial end date:
2023-02-28
Target enrollment:
Participant gender:
Summary
NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated
patients frequently experience debilitating side effects, and many patients delay the start
of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and
fatigue, and rare but serious toxicities include ocular toxicity, hearing loss, and
hematologic toxicity. To date, most of the evidence underlying the current treatment
recommendations has come from observational studies in which either a macrolide has been
combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The
proposed study will answer whether a third drug is necessary or whether taking two drugs can
increase tolerability without a substantial loss of efficacy.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Kevin Winthrop
Collaborators:
Columbia University Emory University Georgetown University Johns Hopkins University Loma Linda University Louisiana State University Health Sciences Center in New Orleans Mayo Clinic Medical University of South Carolina National Jewish Health New York University Northwell Health Patient-Centered Outcomes Research Institute Stanford University Temple University The Oregon Clinic The University of Texas Health Science Center at San Antonio The University of Texas Health Science Center at Tyler University Health Network, Toronto University of California, San Diego University of California, San Francisco University of Chicago University of Iowa University of Kansas University of Miami University of North Carolina University of Washington University of Wisconsin, Madison Vancouver Clinic Weill Medical College of Cornell University Yale University