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A non-randomized pragmatic historically controlled trial evaluating the effectiveness and safety of a bedaquiline or a linezolid-based short regimen for rifampicin-resistant tuberculosis Zacarías, Adriano Terán, Rafael Nindia, Arlete Aixut, Sandra Martínez-Campreciós, Joan Aznar, María Luisa Espinosa-Pereiro, Juan Sulleiro, Elena Tórtola Fernández, María Teresa SÁNCHEZ-MONTALVÁ, ADRIÁN Molina Romero, Israel Institut Català de la Salut [Martínez-Campreciós J, Aznar ML, Espinosa-Pereiro J, Molina I] Unitat de Medicina Tropical i Salut Internacional, Servei de Malalties Infeccioses, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades, Infecciosas, Instituto de Salud Carlos III, Madrid, Spain. [Zacarias A, Terán R] Tuberculosis Unit, Hospital Nossa Senhora da Paz, Cubal, Benguela, Angola. [Nindia A] Laboratory Department, Hospital Nossa Senhora da Paz, Cubal, Benguela, Angola. [Aixut S] Unitat de Medicina Tropical i Salut Internacional, Servei de Malalties Infeccioses, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Tuberculosis Unit, Hospital Nossa Senhora da Paz, Cubal, Benguela, Angola. [Sulleiro E, Tórtola MT] Servei de Microbiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Sánchez-Montalvá A] Unitat de Medicina Tropical i Salut Internacional, Servei de Malalties Infeccioses, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades, Infecciosas, Instituto de Salud Carlos III, Madrid, Spain. Grupo de Estudio de micobacterias, Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica, Madrid, Spain Vall d'Hebron Barcelona Hospital Campus Avaluació de resultats (Assistència sanitària) Tuberculosi - Tractament Resistència als medicaments Medicaments antituberculosos - Ús terapèutic ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents::Antitubercular Agents Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents::Antitubercular Agents Other subheadings::Other subheadings::/therapeutic use TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento ENFERMEDADES::infecciones bacterianas y micosis::infecciones bacterianas::infecciones por bacterias grampositivas::infecciones por Actinomycetales::micobacteriosis::tuberculosis::tuberculosis resistente a múltiples medicamentos Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antibacterianos::antituberculosos Otros calificadores::Otros calificadores::/uso terapéutico Drug-resistance; Pragmatic trial; Tuberculosis Resistència a medicaments; Assaig pragmàtic; Tuberculosi Resistencia a medicamentos; Ensayo pragmático; Tuberculosis Background Short all-oral regimens for Rifampicin-resistant tuberculosis (ShORRT) have been a turning point in the treatment of drug-resistant tuberculosis. Despite this, access to drugs, stockouts, or adverse effects may limit the use of the recommended regimens. Methods Pragmatic non-randomized trial evaluating the efficacy and safety of a ShORRT strategy for the treatment of rifampicin-resistant Tuberculosis (RR-TB) at the Hospital Nossa Senhora da Paz (Angola). The strategy assigned participants to receive a bedaquiline (BDQ) or a linezolid-based (LZF) regimen supplemented with levofloxacin, clofazimine, and cycloserine for up to 9 months. Results One hundred and twenty-one participants with pulmonary RR-TB were treated with the ShORRT strategy; 69 received the bedaquiline- and 52 the linezolid-based regimen. Overall, 98 (81%) participants had successful treatment outcomes, which was significantly higher compared to a 20-month historical injectable-based regimen (successful outcome rate including cure and treatment completed: 53.7%) (p < 0.001). No significant differences between treatment success rates (85.5% vs. 75.0%), treatment failure (0.0% vs. 1.9%), death (5.8% vs. 13.5%), or lost to follow-up (LTFU) (8.7% vs. 9.6%) were seen between the BDQ and the LZF-based regimen. Globally, 72 adverse events (AE) occurred in 36 (29.7%) participants. Eighteen (14.9%) of these were grade ≥3 and were more frequently observed in those receiving the LZD-based regimen (p = 0.02). Conclusion The ShORRT strategy with a nine-month BDQ- or LZD-based regimen supports the efficacy of shorter all-oral regimens for the treatment of RR-TB and presents real-world data from schemes without bedaquiline, nitroimidazole, or injectables. 2024-12-03T13:58:14Z 2024-12-03T13:58:14Z 2024-12 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Martínez-Campreciós J, Aznar ML, Zacarias A, Terán R, Nindia A, Espinosa-Pereiro J, et al. A non-randomized pragmatic historically controlled trial evaluating the effectiveness and safety of a bedaquiline or a linezolid-based short regimen for rifampicin-resistant tuberculosis. J Infect. 2024 Dec;89(6):106291. 0163-4453 https://hdl.handle.net/11351/12303 10.1016/j.jinf.2024.106291 39426632 001353404500001 http://hdl.handle.net/11351/12303 eng Journal of Infection;89(6) https://doi.org/10.1016/j.jinf.2024.106291 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf Elsevier Scientia