Bedaquiline combined with clofazimine as salvage therapy for 11 patients with nontuberculous mycobacterial lung disease
Abstract
Objective: We aimed to investigate the efficacy and safety of a regimen combining bedaquiline and clofazimine in the treatment of refractory nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex(MAC) or Mycobacterium abscessus subsp. abscessus (here Mab).
Methods: In this open-label, prospective pilot study, patients with refractory non-tuberculous mycobacterial pulmonary disease (NTM-PD) were enrolled to receive a regimen of bedaquiline and clofazimine alongside individualized background therapies. No control group was established in the study. Sputum samples were collected for culture at baseline (prior to treatment initiation) and then monthly thereafter. After the initial 6-month period, sputum collection frequency was reduced to every two months until trial completion. The primary end-point was sputum culture conversion rate. However, due to insufficient patient enrollment, we present these findings as a case series.
Results: A total of 11 patients were enrolled in this study, including 8 cases infected with Mycobacterium abscessus subsp. abscessus, 2 with Mycobacterium avium, and 1 with Mycobacterium intracellulare. Nine patients were resistant to clarithromycin. All 11 patients completed 18 months of follow-up. After 6 months of treatment, 45% (5/11) patients achieved culture conversion. However, after 18 months' treatment, only 27% (3/11) maintained culture conversion. Chest CT imaging showed improvement in 5 patients, stability in 4…
How strong is the evidence?
Evidence Hub reads this as a case series, done in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health. Reported size: 11 participants or records.
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