03021nam a2200289 4500 ESSALUD 20260805000739.0 ta t pe ||||| |||| 00| 0 spa d BMG eng Conradie, Francesca Autor 53877 A pragmatic trial of a 6-month strategy for rifampicin-resistant tuberculosis páginas: 2429-2439 Background: Safer, more effective treatment regimens for rifampicin-resistant tuberculosis are needed. Methods: We conducted a phase 3, open-label, pragmatic, randomized, controlled noninferiority trial in South Africa to assess a 6-month treatment strategy for pulmonary rifampicin-resistant tuberculosis. Participants with pulmonary rifampicin-resistant tuberculosis who were 6 years of age or older were randomly assigned to a regimen consisting of bedaquiline, linezolid, delamanid, and levofloxacin or clofazimine or both for 6 months (trial-strategy group) or the 9-month standard-of-care treatment regimen that was current in South Africa (control group). Persons who were pregnant or breastfeeding and those who had fluoroquinolone-resistant tuberculosis were included in the trial population. Treatment in both groups was adjusted on the basis of results of second-line drug susceptibility testing. The primary efficacy end point was a successful outcome (cure or completion of treatment) at the end of treatment and at 76 weeks after randomization. The noninferiority margin was 10 percentage points. The primary safety end point was an adverse event of grade 3 or higher. Results: Among the 432 persons who were screened, 403 underwent randomization; 203 were assigned to the trial-strategy group, and 200 to the control group. A successful outcome was observed in 174 of 202 participants (86.1%) in the trial-strategy group and in 172 of 200 (86.0%) in the control group. The adjusted risk difference was −0.2 percentage points (95% confidence interval [CI], −6.9 to 6.5; P=0.001 for noninferiority). Adverse events of grade 3 or higher occurred during treatment in 63 of 202 participants (31.2%) in the trial-strategy group and in 74 of 200 (37.0%) in the control group; 10 participants in each group died. Conclusions: Among participants in South Africa with rifampicin-resistant tuberculosis, the 6-month trial strategy was noninferior to the standard-of-care strategy with respect to a successful outcome. The safety profiles of the two strategies were similar. INFECCIONES BACTERIANAS 7357 SALUD GLOBAL 10472 ENFERMEDADES INFECCIOSAS 6776 TUBERCULOSIS 1999 Badat, Tasnim 53878 Poswa, Asanda 53879 Rajaram, Shakira 53880 Kooverjee, Shaneen 53881 Maartens, Gary 53882 22717 22639 Massachusetts NEJM Group NEJM006 The New England Journal of Medicine ESSALUD 0028-4793 ARTICULOS 2026-07-31 SQB 22762 22762