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Benznidazole Evaluation for Interrupting Trypanosomiasis - The BENEFIT Trial

This study is currently Recruiting

June 2005 By Population Health Research Institute

First Recieved on July 21, 2005

Last Updated on August 1, 2011

Sponsor: Population Health Research Institute
Collaborators: Canadian Institutes of Health Research (CIHR)
Information provided by: Population Health Research Institute
Identifier: NCT00123916

Purpose

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: - Consenting patients (between 18 and 75 years of age) with serological evidence of Chagas infection (any combination of 2 positive tests) and that have one or more of the following: - Abnormal electrocardiogram with at least two components (complete RBBB or LBBB; left anterior or posterior fascicular block; ventricular premature beat; first degree atrioventricular [AV] block; Mobitz type I AV block; sinus bradycardia; primary ST-T changes; abnormal Q waves; low voltage QRS; or atrial fibrillation); - Abnormal ECG (Mobitz type II, advanced or third degree AV block); - Increased cardiothoracic ratio (> 0.50); - Complex ventricular arrythmias on 24 hour ambulatory ECG monitoring; - Evidence of regional wall motion abnormality or reduced global left ventricular systolic function or increased left ventricular and diastolic diameter on 2D-Echo. Exclusion Criteria: Patients will be excluded if having: - NYHA heart failure class IV or decompensated heart failure - Evidence of concomitant coronary artery disease (CAD) or other etiology of dilated cardiomyopathy - Previous treatment with antitrypanosomal agents or an accepted indication for antiparasitic therapy - Inability to comply with follow-up visits - History of severe alcohol abuse within 2 years - Known chronic renal or hepatic insufficiency or hepatic insufficiency - Pregnancy or breast feeding - Megaesophagus with swallowing impairment - Other severe disease significantly curtailing life expectancy

Investigators

  • Investigator: Carlos Morillo, MD, FRCPC, FAC - Study Chair - Population Health Research Institute - McMaster University
  • Investigator: Jose Antonio Marin-Neto, MD, PhD,FACC - Study Chair - Hospital das Clinicas de Ribeirao Preto/USP
  • Investigator: Salim Yusuf, MD, DPh, FRCPC - Study Chair - Population Health Research Institute - McMaster University
  • Investigator: Sergio Sosa-Estani, MD - Principal Investigator - Argentina National Coordinator - CenDIE, Argentina
  • Investigator: Fernando Rosas - Principal Investigator - Fundacion Clinica Shaio, Bogota, Colombia

Locations

  • BENEFIT Ivestigational Site

    Ciudad Aut?noma de Buenos Aires, apital Federal 3556 Argentina

  • BENEFIT Investigational Site

    Escobar, Buenos Aires 1753 Argentina

  • BENEFIT Investigational Site

    Isidro Casanova, Buenos Aires 1282 Argentina

  • BENEFIT Investigational Site

    San Juan, Buenos Aires 1625 Argentina

  • BENEFIT Investigational Site

    Santiago del Estero, Buenos Aires 5400 Argentina

  • BENEFIT Investigational Site

    Santiago del Estero, Buenos Aires 4200 Argentina

  • BENEFIT Investigational Site

    Ciudad Aut?noma de Buenos Aires, Capital Federal 1063 Argentina

  • BENEFIT Investigational Site

    San Fernando del Valle de Catamarca, Catamarca Argentina

  • BENEFIT Investigational Site

    Charata, Chaco H3730AVI Argentina

  • BENEFIT Investigational Site

    Paran?, Entre Rios 3100 Argentina

  • BENEFIT Investigational Site

    Buenos Aires, General Rodr?guez Partido Argentina

  • BENEFIT Investigational Site

    San Salvador de Jujuy, Jujuy 4600 Argentina

  • BENEFIT Investigational Site

    Corrientes, Rosario, Santa Fe 3400 Argentina

  • BENEFIT Investigational Site

    Rosario, Santa Fe 2000 Argentina

  • BENEFIT Investigational Site

    A?atuya, Santiago del Estero 3760 Argentina

  • BENEFIT Investigational Site

    Santiago Del Estero, Sgo. Del Estero 4200 Argentina

  • BENEFIT Investigational Site

    Buenos Aires, Argentina

  • BENEFIT Investigational Site

    Salta, A4406CLA Argentina

  • BENEFIT Investigational Site

    Tupiza, Potosi Bolivia

  • BENEFIT Investigational Site

    Recife, - Pernambuco 50100-130 Brazil

  • BENEFIT Investigational Site

    Salvador, Bahaia 40425-060 Brazil

  • BENEFIT Investigational Site

    Salvador, Bahaia 40050-410 Brazil

  • BENEFIT Investigational Site

    Salvador, Bahaia 40110-909 Brazil

  • BENEFIT Investigational Site

    Carmo, Belo Horizonte 30130-690 Brazil

  • BENEFIT Investigational Site

    Bras?lia, Brazilian Federal District 70658-700 Brazil

  • BENEFIT Investigational Site

    Goi?nia, GO 74110-020 Brazil

  • BENEFIT Investigational Site

    Goi?nia, GO 74605-050 Brazil

  • BENEFIT Investigational Site

    Goi?nia, GO 74110-010 Brazil

  • BENEFIT Investigational Site

    Uberlandia, MG 38025-440 Brazil

  • BENEFIT Investigational Site

    Uberl?ndia, MG 38400-299 Brazil

  • BENEFIT Investigational Site

    Uberaba, Minas Gerais 38010-160 Brazil

  • BENEFIT Investigational Site

    Curitiba, Parana 80060-900 Brazil

  • BENEFIT Investigational Site

    Pelotas, Rio Grande do Sul 96015-290 Brazil

  • BENEFIT Investigational Site

    Campinas, S?o Paulo 13059-740 Brazil

  • BENEFIT Investigational Site

    Ribeir?o Preto, S?o Paulo 14048-900 Brazil

  • BENEFIT Investigational Site

    S?o Jos? do Rio Preto, S?o Paulo 15090-000 Brazil

  • BENEFIT Investigational Site

    S?o Jos? do Rio Preto, S?o Paulo 15015-210 Brazil

  • BENEFIT Investigational Site

    Votuporanga, S?o Paulo 15500-003 Brazil

  • BENEFIT Investigational Site

    Rio de Janeiro, 21941-913 Brazil

  • BENEFIT Investigational Site

    Rio de Janeiro, 21040-360 Brazil

  • BENEFIT Investigational Site

    S?o Paulo, 05403-000 Brazil

  • BENEFIT Investigational Site

    S?o Paulo, 04012-909 Brazil

  • BENEFIT Investigational Site

    S?o Paulo, 05403-901 Brazil

  • BENEFIT Investigational Site

    S?o Paulo, 01417 010 Brazil

  • BENEFIT Investigational Site

    Bogota, Bogot? Colombia

  • BENEFIT Investigational Site

    San Gil, Santander Colombia

  • BENEFIT Ivestigational Site

    San Salvador, El Salvador

Conditions related to this trial:

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