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Abstract Background Safer, more effective treatment regimens for rifampicin-resistant tuberculosis are needed. We evaluated a novel six-month RR-TB treatment strategy. Methods We conducted a phase III, open-label, multi-centre, pragmatic, noninferiority randomised-controlled strategy trial in South Africa to assess the effectiveness and safety of a 6-month strategy for individuals with pulmonary RR-TB. Participants aged six years and older, including pregnant and breastfeeding women and those with fluoroquinolone resistance, were randomised to receive either a 6-month strategy regimen of bedaquiline, delamanid, linezolid, levofloxacin and /or clofazimine (BDLLfxC) (Study Strategy) or the then-current South African nine-month, or longer regimen(Control Strategy). Treatment for both groups was adjusted based on the second-line drug susceptibility test results. The primary effectiveness measure was successful treatment completion at the end of treatment and a successful end-of-follow-up (76 weeks) outcome, compared using an adjusted risk difference with a 10% non-inferiority margin. Results Of 432 individuals screened, 403 were randomised (203 and 200 to the control and study strategies, respectively). One participant in the study strategy arm never started treatment. Successful outcomes were achieved in 172/200 (86.0%) and 174/202 (86.1%) in the control and study strategies, respectively; the adjusted risk difference was -0.2% (95% CI -6.9% to 6.5%), demonstrating non-inferiority (p=0.0014 test for non-inferiority). Seventy-four (37.0%) and 63 (31.2%) in the control and study strategies, respectively, experienced severe adverse events during treatment; 10 participants in each strategy died. Conclusions The 6-month study strategy regimen demonstrated non-inferior effectiveness and safety comparable to the South African standard-of care-TB regimen. Trial registration number NCT04062201
Conradie et al. (Tue,) studied this question.