Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease

• Status: Recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Anti-Bacterial Agents; Azithromycin; Ethambutol; Rifampin

Criteria

Inclusion Criteria:

• Culture positive pulmonary MAC meeting ATS/IDSA disease criteria

• Age over 18 years

• Ability to provide informed consent

Exclusion Criteria:

• Fibrocavitary disease

• Planned surgery for MAC disease

• Patients who have cumulatively taken 6 weeks or more of multi-drug antimicrobial treatment for MAC

• Patients who are currently taking or have taken multi-drug antimicrobial treatment for NTM within the prior 30 days

• Diagnosis of Cystic fibrosis

• Diagnosis of HIV

• History of solid organ or hematologic transplant

• Significant drug-drug interaction not clinically manageable in the opinion of the investigator

• Contraindication to any component of the study treatment regimen