Evaluation of an oral bedaquiline regimen for treating multidrug-resistant TB in China: a randomized trial
Abstract
Introduction: Bedaquiline (BDQ) is recommended in China as component of oral short-course regimens (SCR) for MDR-TB patients. However, the efficacy and safety of BDQ containing oral SCRs remain insufficiently validated in large-scale, well-designed clinical trials involving the Chinese population.
Methods: A randomized, non-inferiority, open-label trial was conducted at 17 hospital clinics in China, enrolling adult patients with MDR-TB. Participants were assigned in a 1:1 ratio to receive either a 40-week oral BDQ-containing SCR or a 40-week oral non BDQ-containing SCR. The primary endpoint was the proportion of participants achieving favorable outcome at the end of treatment. The non-inferiority margin of the difference in proportion between the BDQ and control groups in the modified intent-to-treat (mITT) population was set at -15%.
Results: A total of 217 participants were randomized. Among 182 patients in the mITT population, the BDQ-containing SCR group achieved an 80.0% favorable outcome compared to 59.8% in the non-BDQ group, with an adjusted difference of 22.27% (95% CI 9.41-35.13%). BDQ-containing SCR was also associated with higher proportions of modified favorable outcomes and cure rates. Additionally, BDQ-containing SCR resulted in a higher culture conversion rate at the end of treatment and a shorter time to culture conversion. Serious adverse events occurred in 16 of 110 participants (14.5%) in the BDQ-containing SCR group and 25 of 107 participants (23.4%) in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 217 participants or records.
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