Efficacy and safety assessment of different dosage of benznidazole 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 expert consensus

by Molina-Morant D, Fernández 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. Trials 2020, 21:328. doi: 10.1186/s13063-020-4226-2 

Summary: Despite modest cure rates in adult chronic patients and its safety profile, benznidazole is the drug of choice to treat Chagas disease. Both the currently recommended dose and duration of treatment are under discussion and may be optimized. The authors describe a study protocol for a phase II, randomized, non-inferiority, double-blind, multicentre international clinical trial, MULTIBENZ, to assess different dose schemes of benznidazole compared with the standard treatment regimen for the treatment of Chagas disease in the chronic phase. MULTIBENZ may help to clarify which is the most adequate benznidazole regimen in terms of efficacy and safety, predicated on sustained parasitic load suppression in peripheral blood.

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