Last updated on August 2011

BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease


Brief description of study

Evaluate if benznidazole, an antiparasite drug, given at a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment - period adjusted according to the patient's body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg) - reduces morbidity and mortality in patients with Chronic Chagas' Cardiomyopathy (CCC). The BENEFIT study is being conducted by the Population Health Research Institute (in Hamilton, Canada) and the Institute Dante Pazzanese de Cardiologia (Sao Paulo, Brazil) together with an independent Steering Committee.

Detailed Study Description

A randomized double-blind controlled clinical trial investigating the role of benznidazole in patients with chronic Chagas' heart disease. Chagas disease has 3 phases: acute, undetermined and chronic phases. There are no clinical trials up to date that have investigated the use of antiparasitic drugs in patients that are in the chronic phase. This study will evaluate the efficacy and safety of benznidazole (an antiparasitic drug) in patients with chronic Chagas' heart disease. Evaluate if benznidazole, an antiparasite drug, given at a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment - period adjusted according to the patient's body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg) - reduces morbidity and mortality in patients with Chronic Chagas' Cardiomyopathy (CCC). It will be developed in 54 study centres in Argentina, Bolivia,Brazil,Colombia and El Salvador - countries with high incidence of Chagas Disease. The Pilot study is evaluating if benznidazole is effective in producing parasitic cure (PCR negativization or reducing parasitic load) in chronic Chagas Disease as well as assessing the feasibility of conducting a large trial in chronic Chagas Disease in South America.

Clinical Study Identifier: NCT00123916

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Carlos A. Morillo, MD

BENEFIT Ivestigational Site
Ciudad Autónoma de Buenos Aires, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Escobar, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Isidro Casanova, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
San Juan, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Santiago del Estero, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
San Fernando del Valle de Catamarca, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Charata, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Paraná, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Buenos Aires, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
San Salvador de Jujuy, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Corrientes, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Rosario, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Añatuya, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Santiago Del Estero, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Salta, Argentina
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Tupiza, Bolivia
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Recife, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Salvador, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Carmo, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Brasília, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Goiânia, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Uberlandia, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Uberlândia, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Uberaba, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Curitiba, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Pelotas, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Campinas, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Ribeirão Preto, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
São José do Rio Preto, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Votuporanga, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Rio de Janeiro, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
São Paulo, Brazil
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Carlos A. Morillo, MD

BENEFIT Investigational Site
Bogota, Colombia
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Carlos A. Morillo, MD

BENEFIT Investigational Site
San Gil, Colombia
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Carlos A. Morillo, MD

BENEFIT Ivestigational Site
San Salvador, El Salvador
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Recruitment Status: Open


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