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

Completed · Phase 2/Phase 3

Conditions studied: Mycobacterium Avium Complex, Nontuberculous Mycobacterium Infection

In brief

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.

Key facts

Study ID

NCT03672630

Run by

Kevin Winthrop

People needed

474

Starts

2019-02-22

Expected to finish

2026-01-08

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Culture positive pulmonary MAC meeting ATS/IDSA disease criteria
• Age over 18 years
• Ability to provide informed consent

You may not qualify if…

• 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

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States
• University of California, San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• National Jewish Health — Denver, Colorado, United States
• University of Miami — Miami, Florida, United States
• Tampa VA Medical Center — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Kaiser Permanente Hawaii — Honolulu, Hawaii, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas — Kansas City, Kansas, United States
• Louisina State University — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Northwell Health — Manhasset, New York, United States
• New York University — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Health Science Center — Tyler, Texas, United States
• University of Washington — Seattle, Washington, United States
• Vancouver Clinic — Vancouver, Washington, United States
• University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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