ArticleThe Journal of antimicrobial chemotherapy2026
Enhanced antimycobacterial efficacy of simulated inhaled clofazimine versus oral clofazimine in combination with azithromycin and ethambutol in a hollow-fiber system.
Article in The Journal of antimicrobial chemotherapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
BACKGROUND AND
objectivesTreatment outcomes in Mycobacterium avium complex pulmonary disease may be improved by adding clofazimine, instead of rifampicin, to the azithromycin-ethambutol backbone. Inhalation of clofazimine instead of oral administration has been suggested to increase the antibiotic concentration at the site of infection and to improve its efficacy, while minimizing systemic exposure and adverse effects. We evaluated the efficacy of inhaled clofazimine compared to oral clofazimine with an azithromycin-ethambutol backbone against M. avium.
methodsWe simulated pharmacokinetic exposures to azithromycin, ethambutol and either inhalational or oral clofazimine administration in an in vitro hollow-fiber system during 3 weeks. Intracellular and extracellular Mycobacterium avium ATCC 700898 bacteria were exposed to these antibiotic regimens and bacterial densities were enumerated at day 0, 3, 7, 14 and 21. The development of macrolide resistance was assessed by inoculation of agar plates containing azithromycin. Pharmacokinetic exposures were confirmed on day 0 and 21.
resultsInhalational administration of clofazimine significantly increased the antimycobacterial effect of the regimen against both intracellular and extracellular bacteria. The inhaled treatment showed an intracellular kill rate of 0.62 (95%C.I. 0.61-0.64) per day, while the oral administration showed a kill rate of 0.55 (95%C.I. 0.54-0.56) per day. For the extracellular fraction, inhaled administration showed a kill rate of 0.56 (95%C.I. 0.55-0.58) per day and the oral administration a kill rate of 0.50 (95%C.I. 0.50-0.51) per day. Inhaled clofazimine exposures reduced and delayed the emergence of macrolide resistance.
conclusionsInhalation of clofazimine with an azithromycin-ethambutol backbone increases treatment efficacy and decreases the development of macrolide resistance compared to oral administration in a hollow-fiber system. This calls for a clinical trial of inhaled clofazimine.
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