A pragmatic trial of a 6-month strategy for rifampicin-resistant tuberculosis (Registro nro. 22762)

000 -Cabecera
Campo de control interno 03021nam a2200289 4500
001 - Número de control
control field ESSALUD
005 - Fecha y hora de la última transacción
Campo de control 20260805000739.0
007 - Tipo material - Descripcion fisica - info general
Tipo material - Descripcion fisica - info general ta
008 - Elementos de Longitud Fija - Información General
Elementos de Longitud Fija - Información t pe ||||| |||| 00| 0 spa d
040 ## - Origen de la Catalogación
Origen de la Catalogación BMG
041 ## - Idioma
Idioma eng
100 ## - Autor
Autor Conradie, Francesca
Rol del Autor Autor
9 (RLIN) 53877
245 ## - Titulo
Titulo A pragmatic trial of a 6-month strategy for rifampicin-resistant tuberculosis
300 ## - Páginas
Paginación páginas: 2429-2439
520 ## - Resumen
Resumen Background: Safer, more effective treatment regimens for rifampicin-resistant tuberculosis are needed.<br/>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.<br/>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.<br/>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.
650 ## - Temas - Descriptores
Temas - Descriptores INFECCIONES BACTERIANAS
9 (RLIN) 7357
650 ## - Temas - Descriptores
Temas - Descriptores SALUD GLOBAL
9 (RLIN) 10472
650 ## - Temas - Descriptores
Temas - Descriptores ENFERMEDADES INFECCIOSAS
9 (RLIN) 6776
650 ## - Temas - Descriptores
Temas - Descriptores TUBERCULOSIS
9 (RLIN) 1999
700 ## - Autor Personal
Autor Personal Badat, Tasnim
9 (RLIN) 53878
700 ## - Autor Personal
Autor Personal Poswa, Asanda
9 (RLIN) 53879
700 ## - Autor Personal
Autor Personal Rajaram, Shakira
9 (RLIN) 53880
700 ## - Autor Personal
Autor Personal Kooverjee, Shaneen
9 (RLIN) 53881
700 ## - Autor Personal
Autor Personal Maartens, Gary
9 (RLIN) 53882
773 0# - Revista (Relacion con el numero)
Host Biblionumber 22717
Host Itemnumber 22639
Ciudad, Editorial Massachusetts NEJM Group
Codigo barras item/ejemplar NEJM006
Titulo de la Revista The New England Journal of Medicine
Número de control de registro ESSALUD
ISSN 0028-4793
942 ## - Elementos de Koha
Tipo de Documento Artículos
Fecha procesamiento 2026-07-31
Catalogador SQB

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