Trial reportInfection2026
Evaluation of an oral bedaquiline regimen for treating multidrug-resistant TB in China: a randomized trial.
Trial report in Infection, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05306223 (A Pragmatic Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Patients With Multidrug-resistant Tuberculosis in China), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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A Pragmatic Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Patients With Multidrug-resistant Tuberculosis in China
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25 authors.
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No grant is acknowledged in the PubMed record.
Abstract
introductionBedaquiline (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.
methodsA 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%.
resultsA 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 the non-BDQ-containing SCR group.
conclusion40-week BDQ-SCR proved non-inferior and superior, safe, and well tolerated in Chinese patients with MDR-TB. Further investigation into the long-term safety and efficacy of the BDQ-containing regimen is still needed in China. CLINICALTRIALS: gov NCT05306223. Prospectively registered on 16 March 2022.
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