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

21:59 EDT 21st August 2014 | BioPortfolio

Summary

The purpose of this study is to determine if 60 days of treatment with an antiparasitic drug (benznidazole) could prevent the progression of cardiac disease in patients with Chagas disease.

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.

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. It will evaluate if 60 days of drug treatment will reduce mortality and morbidity in patients with chronic Chagas' heart disease on several outcomes. It will be developed in 75 study centres in Argentina, Brazil, Colombia, Venezuela, Peru and Bolivia - countries with high incidence of Chagas Disease.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Chagas Disease

Intervention

Benznidazole

Location

CenDIE
Buenos Aires
Sao Paulo
Argentina
14090-100

Status

Recruiting

Source

McMaster University

Results (where available)

View Results

Links

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PubMed Articles [14503 Associated PubMed Articles listed on BioPortfolio]

Sesquiterpene lactone in nanostructured parenteral dosage form is efficacious in experimental Chagas disease.

Drugs available for Chagas disease treatment are toxic and ineffective. We studied the in vivo activity of a new drug, lychnopholide (LYC). LYC was loaded in nanocapsules (NC) and its effects were com...

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Cytotoxic, mutagenic and genotoxic evaluation of crude extracts and fractions from Piper jericoense with trypanocidal action.

The current Chagas disease treatment is based on two drugs, nifurtimox and benznidazole, which is considered unsatisfactory, not only because of the narrow therapeutic range but also because of the as...

Medical and Biotech [MESH] Definitions

A disease of the CARDIAC MUSCLE developed subsequent to the initial protozoan infection by TRYPANOSOMA CRUZI. After infection, less than 10% develop acute illness such as MYOCARDITIS (mostly in children). The disease then enters a latent phase without clinical symptoms until about 20 years later. Myocardial symptoms of advanced CHAGAS DISEASE include conduction defects (HEART BLOCK) and CARDIOMEGALY.

Infection with the protozoan parasite TRYPANOSOMA CRUZI, a form of TRYPANOSOMIASIS endemic in Central and South America. It is named after the Brazilian physician Carlos Chagas, who discovered the parasite. Infection by the parasite (positive serologic result only) is distinguished from the clinical manifestations that develop years later, such as destruction of PARASYMPATHETIC GANGLIA; CHAGAS CARDIOMYOPATHY; and dysfunction of the ESOPHAGUS or COLON.

A nitrovinyl furan used as a schistosomicidal agent and proposed for trypanosomiasis, especially Chagas disease.

The agent of South American trypanosomiasis or CHAGAS DISEASE. Its vertebrate hosts are man and various domestic and wild animals. Insects of several species are vectors.

A subfamily of assassin bugs (REDUVIIDAE) that are obligate blood-suckers of vertebrates. Included are the genera TRIATOMA; RHODNIUS; and PANSTRONGYLUS, which are vectors of TRYPANOSOMA CRUZI, the agent of CHAGAS DISEASE in humans.

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