BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease
Condition: Chagas Disease; Trypanosomiasis; Heart Disease
MeSH terms: Chagas Disease; Trypanosomiasis; Heart Diseases
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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 49 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.
    

Intervention name(s): Benznidazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily po Benznidazole or placebo (weight based) during 40 - 80 days (depending on body weight); 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)
Other intervention name(s): Rochagan/LaFepe; Rochagan/LaFepe
Intervention MeSH terms: Benzonidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chagas Disease; Trypanosomiasis; Benznidazole; Chronic Heart disease; Trypanosoma Cruzi