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| Name | Class |
|---|---|
| Chemo Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benznidazole | Experimental | Benznidazole 100 mg Tablets or Benznidazole 12.5 mg Tablets by mouth, every 12 hours for 60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benznidazole | Drug | Drug: Benznidazole Tablets 100 mg (functionally scored) or Tablets 12.5 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 72-month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Serological Cure by Conventional ELISA at different timepoints | Percentage of patients with negative conventional ELISA results as a measure of serological cure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Rate and severity of adverse events (AEs) | Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up |
| Population Pharmacokinetic - blood concentration | Benznidazole blood concentrations |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Ninos "Dr. Ricardo Gutierrez" | Buenos Aires | Argentina | ||||
| Hospital "Luis Carlos Lagomaggiore" |
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| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| C009999 | benzonidazole |
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Historical control-based comparison, single-arm assignment, multicentre study
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Percentage of patients with two negative conventional serology results as a measure of serological cure |
| 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 | 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 | 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 | Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up |
| Cure by qPCR at different timepoints | Consistently negative quantitative polymerase chain reaction (qPCR) results as a surrogate measure of cure | 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 | 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 | 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 | 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 | 48 and 72 months of follow-up |
| pre-dose, day 7 and day 30 |
| Population Pharmacokinetic - area under the curve (AUC) | Benznidazole area under the curve (AUC) | pre-dose, day 7 and day 30 |
| Population Pharmacokinetic - volume of distribution | Benznidazole volume of distribution | pre-dose, day 7 and day 30 |
| Intensive Pharmacokinetic - blood concentrations | Benznidazole blood concentrations | Day 1 or day 7 |
| Intensive Pharmacokinetic - area under the curve (AUC) | Benznidazole area under the curve (AUC) | Day 1 or day 7 |
| Mendoza |
| Argentina |
| Hospital Pediatrico "Dr. Humberto Notti" | Mendoza | Argentina |
| Hospital Público Descentralizado Dr. Guillermo Rawson | 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 |
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |