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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B300/60 | Active Comparator | Benznidazole 300mg/day p.o. divided in two doses for 60 days |
|
| B150/60 | Experimental | Benznidazole 150mg/day p.o. divided in two doses for 60 days |
|
| B400/15 | Experimental | Benznidazole 400mg/day p.o. divided in two doses for 15 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benznidazole | Drug | To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Israel Molina, PhD | Hospital Universitario Vall d'Hebron Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Parasitología Dr. Mario Fatala Chaben (ANLIS) | Buenos Aires | Argentina | ||||
| Instituto de Cardiología de Corrientes Juana Francisca Cabral |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38218195 | Derived | 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. | |
| 32293523 |
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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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|
| 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 |
| Derived |
| 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. |
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |