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

18819

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.

2019-02-22

2025-02-28

2025-02-28

Recruiting

Early phase I

500

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}

2024-03-27