Clofazimine in the Treatment of
Pulmonary Mycobacterium Avium Complex

The purpose of this study is to evaluate the clinical effectiveness and safety of clofazimine when used to treat Mycobacteria avium complex (MAC) lung disease. Clofazimine has been used for many years off-label against other Mycobacteria, including Mycobacteria avium complex (MAC) lung disease, an increasingly prevalent infection in older Americans. However, to date, there is little understanding of the benefits and risks of clofazimine when used to treat MAC lung disease. This study is a randomized, placebo-controlled clinical trial to assess the clinical efficacy and safety of clofazimine. To be eligible, participants must have MAC lung disease, positive sputum cultures for MAC, and not currently taking antibiotics for MAC. Eligible participants (102 total enrolled) will be randomly given either clofazimine or placebo for 6 months, and followed closely by their treating physician. The percentage of participants who become culture negative in each group will be compared, as it is suspected that participants treated with clofazimine will be more likely to become culture negative. The safety of clofazimine will be measured as well as other potential benefits of the therapy including changes in lung function and quality of life.

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