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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
238
To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease
Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS)
Buenos Aires, Argentina
Instituto de Cardiología de Corrientes Juana Francisca Cabral
Corrientes, Argentina
Centro de Pesquisas René Rachou - Fundação Oswaldo Cruz. (FIOCRUZ)
Belo Horizonte, Brazil
Hospital Universitário Clemente de Faria
Montes Claros, Brazil
Fundación Cardioinfantil - Instituto de Cardiología
Bogotá, Colombia
Centro Atencion y Diagnóstico de Enfermedades Infecciosas
Bucaramanga, Colombia
Infectious Disease Department Vall d'Hebron Hospital
Barcelona, Spain
Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
The treatment efficacy is assessed through the proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
Time frame: 12 months
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