New regimens of benznidazole for the treatment of chronic Chagas disease in adult participants in indeterminate form or with mild cardiac progression (NuestroBen study): protocol for a phase III randomised, multicentre non-inferiority clinical trial

by Marques T, Forsyth C, Barreira F, Lombas C, Blum de Oliveira B, Laserna M, Molina I, Bangher M C, Fernández R J, Lloveras S, Fernández M L, Scapellato P, Patterson P, Garcia W, Ortiz L, Schijman A, Moreira O C, García L, Viele K, Longhi S, Vaillant M, Tipple C, Fraisse L, Silvestre-Sousa A, Sosa-Estani S, Pinazo M J. BMJ Open 2025, 15:e098079. doi: 10.1136/bmjopen-2024-098079 

Summary: Current treatments for Chagas disease, nifurtimox and benznidazole (BZN), are lengthy and have safety concerns. Recent studies suggest that reduced-duration regimens may be equally effective while enhancing safety. The authors of this manuscript outline a protocol for NuestroBen, a phase III, randomised, clinical trial to assess whether shorter regimens of BZN are non-inferior to the standard 8-week treatment. 540 adults in the chronic phase of Chagas disease with no evidence of organ damage or with mild cardiac progression will be recruited at eight study sites in Argentina and Bolivia and randomised to receive 300 mg BZN daily for 2, 4, or 8 weeks. The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up.

The post New regimens of benznidazole for the treatment of chronic Chagas disease in adult participants in indeterminate form or with mild cardiac progression (NuestroBen study): protocol for a phase III randomised, multicentre non-inferiority clinical trial first appeared on DNDi.

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