CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 474 enrolled
Drug / intervention
Azithromycin +2 moredrug
Likely dose
Azithromycin 500 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03672630
NCT03672630Phase 3Completed
CompareCT.gov

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

Kevin Winthrop·interventional·Posted Sep 14, 2018·Updated Feb 2, 2026

In Brief

A Phase 3 clinical trial evaluating Azithromycin, Ethambutol, and 1 other intervention for Mycobacterium Avium Complex and Nontuberculous Mycobacterium Infection. Completed, enrolled 474 participants across 26 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMycobacterium Avium Complex, Nontuberculous Mycobacterium Infection
CountriesCanada, United States
CollaboratorsPatient-Centered Outcomes Research Institute, National Jewish Health, The University of Texas Health Science Center at Tyler, University Health Network, Toronto, New York University, Medical University of South Carolina, Mayo Clinic, Louisiana State University Health Sciences Center in New Orleans, University of California, San Diego, Stanford University, University of Kansas, Vancouver Clinic, University of California, San Francisco, University of Washington, Johns Hopkins University, University of Miami, Emory University, University of Iowa, University of North Carolina, Temple University, Loma Linda University, Columbia University, University of Wisconsin, Madison, Northwell Health, Kaiser Permanente, James A. Haley Veterans Administration Hospital

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 14, 2018
Enrollment StartFeb 22, 2019
Primary CompletionJan 8, 2026
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 7.8 years ago

Interventions

Azithromycindrug

Azithromycin 500 MG Oral Tablet \[ZITHROMAX\]

Ethambutoldrug

Ethambutol 25 mg/kg \[MYAMBUTOL\]

Rifampindrug

Rifampin 600 MG \[RIFADIN\]