Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.

Summary

A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment of chronic Chagas disease in adult patients. The efficacy is assessed through the proportion of patients with negative parasitaemia measured by Polymerase Chain Reaction (PCR) during the first 12 months after starting treatment. The study will be performed in Spain, Brazil, Argentina and Colombia.

Timeline

Start

2017-04-21

Primary completion

2020-09-21

Completion

2021-03-16

Publications

• Bosch-Nicolau P, Fernandez ML, Sulleiro E, Villar JC, Perez-Molina JA, Correa-Oliveira R, Sosa-Estani S, Sanchez-Montalva A, Del Carmen Bangher M, Moreira OC, Salvador F, Mota Ferreira A, Eloi-Santos SM, Serre-Delcor N, Ramirez JC, Silgado A, Oliveira I, Martin O, Aznar ML, Ribeiro ALP, Almeida PEC, Chamorro-Tojeiro S, Espinosa-Pereiro J, de Paula AMB, Vaquiro-Herrera E, Tur C, Molina I; MULTIBENZ Study Group. Efficacy of three benznidazole dosing strategies for adults living with chronic Chagas disease (MULTIBENZ): an international, randomised, double-blind, phase 2b trial. Lancet Infect Dis. 2024 Apr;24(4):386-394. doi: 10.1016/S1473-3099(23)00629-1. Epub 2024 Jan 11.
• Molina-Morant D, Fernandez ML, Bosch-Nicolau P, Sulleiro E, Bangher M, Salvador F, Sanchez-Montalva A, Ribeiro ALP, de Paula AMB, Eloi S, Correa-Oliveira R, Villar JC, Sosa-Estani S, Molina I. Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II non-inferiority clinical trial. Trials. 2020 Apr 15;21(1):328. doi: 10.1186/s13063-020-4226-2.

Drugs

Indications