• Sanne M H Zweijpfenning, Rob Aarnoutse, Martin J Boeree, Cecile Magis-Escurra, Ralf Stemkens, Bram Geurts, Jakko van Ingen, and Wouter Hoefsloot.
• Department of Pulmonary Diseases, TB Expert Center, Research Institute for Medical Innovation, Radboud University Medical Center, Radboudumc Center for Infectious Diseases, Nijmegen, The Netherlands. Electronic address: sanne.zweijpfenning@radboudumc.nl.
• Chest. 2024 May 1; 165 (5): 108210921082-1092.

BackgroundResults of retrospective studies have suggested clofazimine as an alternative for rifampicin in the treatment of Mycobacterium avium complex pulmonary disease (MAC-PD).Research QuestionIs a treatment regimen consisting of clofazimine-ethambutol-macrolide noninferior to the standard treatment regimen (rifampicin-ethambutol-macrolide) in the treatment of MAC-PD?Study Design And MethodsIn this single-center, nonanonymized clinical trial, adult patients with MAC-PD were randomly assigned in a 1:1 ratio to receive rifampicin or clofazimine as adjuncts to an ethambutol-macrolide regimen. The primary outcome was sputum culture conversion following 6 months of treatment.ResultsForty patients were assigned to receive either rifampicin (n = 19) or clofazimine (n = 21) in addition to ethambutol and a macrolide. Following 6 months of treatment, both arms showed similar percentages of sputum culture conversion based on an intention-to-treat analysis: 58% (11 of 19) for rifampicin and 62% (13 of 21) for clofazimine. Study discontinuation, mainly due to adverse events, was equal in both arms (26% vs 33%). Based on an on-treatment analysis, sputum culture conversion following 6 months of treatment was 79% in both groups. In the clofazimine arm, diarrhea was more prevalent (76% vs 37%; P = .012), while arthralgia was more frequent in the rifampicin arm (37% vs 5%; P = .011). No difference in the frequency of corrected QT interval prolongation was seen between groups.InterpretationA clofazimine-ethambutol-macrolide regimen showed similar results to the standard rifampicin-ethambutol-macrolide regimen and should be considered in the treatment of MAC-PD. The frequency of adverse events was similar in both arms, but their nature was different. Individual patient characteristics and possible drug-drug interactions should be taken into consideration when choosing an antibiotic regimen for MAC-PD.Clinical Trial RegistrationEudraCT; No.: 2015-003786-28; URL: https://eudract.ema.europa.eu.Copyright © 2024. Published by Elsevier Inc.

38 keywords...

hide…