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Clinical Trial 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.


Clinical Trial Description

Mycobacterium avium complex (MAC) are a subset of nontuberculous mycobacteria (NTM), environmental bacteria that can cause chronic, debilitating pulmonary disease, primarily affecting those over age 60. The goals of treatment are to improve symptoms, stop disease progression, and clear the infection. We propose to address a longstanding controversy in the therapy of pulmonary MAC disease, whether patients must take three antibiotics concomitantly, or if two are sufficient. The study is a multicenter randomized pragmatic clinical trial to compare azithromycin + ethambutol (2-drug therapy) vs. azithromycin + ethambutol + rifampin (3-drug therapy) for non-cavitary pulmonary MAC disease. All clinical outcomes will be considered standard of care and abstracted from clinical records. Therapy changes and adverse events will be recorded at routine visits. Health-related quality of life (HRQoL) and self-reported toxicity will be captured centrally in a web-based database, and CT scans will be read centrally. Co-primary outcomes are culture conversion and tolerability of treatment. The primary analysis for culture conversion will be conducted as a per-protocol non-inferiority analysis, and the primary analysis for tolerability will be conducted as an intention-to-treat superiority analysis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03672630
Study type Interventional
Source Oregon Health and Science University
Contact Naomi DeBacker
Phone 503-346-3435
Email debacken@ohsu.edu
Status Recruiting
Phase Phase 2/Phase 3
Start date February 22, 2019
Completion date February 28, 2025

See also
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Withdrawn NCT01719042 - Improving Tolerance of Treatment of Pulmonary MAC Infections Phase 2
Completed NCT00600769 - Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM) Phase 4
Recruiting NCT03236987 - CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections Phase 3
Recruiting NCT04287049 - A Study of Standard Drugs for Mycobacterium Avium Complex Phase 2
Completed NCT04685720 - A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients N/A
Terminated NCT04553406 - Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease Phase 2
Completed NCT00598962 - Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease Phase 4
Recruiting NCT05824988 - Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease
Recruiting NCT02968212 - Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Phase 2