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

Summary

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 a Steering Committee, and an independent Safety Monitoring Board.

Conditions

• Chagas Disease
• Trypanosomiasis
• Heart Disease

Interventions

DRUG

Benznidazole

Daily po Benznidazole or placebo (weight based) during 40 - 80 days (depending on body weight)

DRUG

Placebo

a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 - 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)

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• World Health Organization

  collaborator OTHER

• Instituto Dante Pazzanese de Cardiologia

  collaborator OTHER

• University of Sao Paulo

  collaborator OTHER

• Population Health Research Institute

  lead OTHER

Principal Investigators

• Carlos Morillo, MD · Population Health Research Institute - McMaster University

• Jose Antonio Marin-Neto, MD, PhD · University of Sao Paulo

• Salim Yusuf, MD, DPh · Population Health Research Institute - McMaster University

• Sergio Sosa-Estani, MD, PhD · Argentina National Coordinator - CenDIE, Argentina

• Fernando Rosas, M.D. · Fundacion Clinica Shaio, Bogota, Colombia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2004-11-30

Primary Completion

2015-07-31

Completion

2015-08-31

Countries

• Argentina
• Bolivia
• Brazil
• Colombia
• El Salvador

Study Locations