This study evaluate the efficacy and safety of benznidazole in the treatment of chronic indeterminate Chagas disease in children. All subjects will receive benznidazole and results will be compared to historically to a placebo arm.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
178
Drug: Benznidazole Tablets 100 mg (functionally scored) or Tablets 12.5 mg
Hospital de Ninos "Dr. Ricardo Gutierrez"
Buenos Aires, Argentina
Hospital "Luis Carlos Lagomaggiore"
Mendoza, Argentina
Hospital Pediatrico "Dr. Humberto Notti"
Mendoza, Argentina
Hospital Público Descentralizado Dr. Guillermo Rawson
Serological Cure by Conventional ELISA
Percentage of patients with negative conventional ELISA results as a measure of serological cure at the end of the 72-month follow up
Time frame: 72-month follow up
Serological Cure by Conventional ELISA at different timepoints
Percentage of patients with negative conventional ELISA results as a measure of serological cure
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Serological Cure by two conventional serology tests at 72 month
Percentage of patients with two negative conventional serology results as a measure of serological cure
Time frame: 72 months of follow-up
Serological Cure by two conventional serology tests at 48 months
Percentage of patients with two negative conventional serology results as a measure of serological cure
Time frame: 48 months of follow-up
Serological Cure by three serology tests at different timepoints
Percentage of patients with three negative serology results as a measure of serological cure
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Serological Cure by Non-Conventional ELISA at different timepoints
Percentage of patients with negative non-conventional ELISA (F29) results as a measure of serological cure
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Cure by qPCR at different timepoints
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San Juan, Argentina
Centro de Enfermedad de Chagas y Patologías Regionales
Santiago del Estero, Argentina
Antigua Hospital Viedma
Cochabamba, Bolivia
CEADES - Plataforma de Chagas Sucre
Sucre, Bolivia
Fundación Salud para el Trópico
Santa Marta, Colombia
Centro de Atención e Investigación Médica (CAIMED)
Yopal, Colombia
Consistently negative quantitative polymerase chain reaction (qPCR) results as a surrogate measure of cure
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Serological titres reduction at different timepoints
Reduction of conventional and nonconventional serological titres over the period of follow-up
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Progression of clinical disease at different timepoints
Percentage of patients with progression to clinical disease over the period of follow-up
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Progression of clinical disease and serological cure by one assay at different timepoints
Percentage of patients with no evidence of established cardiomyopathy over the period of follow-up and seroconversion to negative by one assay
Time frame: 48 and 72 months of follow-up
Progression of clinical disease and serological cure by two assays at different timepoints
Percentage of patients with no evidence of established cardiomyopathy over the period of follow-up and seroconversion to negative by two assay
Time frame: 48 and 72 months of follow-up