Chagas' disease (chronic) with heart involvement
Conditions
Interventions
This is an observational study with an aninated randomized clinical trial. With one arm where an experimental intervention will be carried out for the evaluation of the effectiveness and safety of Ben
D27.505.954.122.250.100.875
Sponsors
Instituto Nacional de Infectologia Evandro Chagas
Ministerio da Saúde
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Both sexes; older than 18 years; having two positive serological tests for Chagas disease; weight between 50 kg and 95 kg
Exclusion criteria
Exclusion criteria: Previous treatment with Benznidazole or Nifurtimox, pregnant women, breastfeeding or expressing gestational desire for the next 2 months; Any concomitant use or documented history of use of allopurinol or antifungals ketoconazole, itraconazole and posaconazole; History of hypersensitivity, allergic or severe adverse reactions to any nitroimidazole compound and/or its components; liver disease with liver failure and kidney disease requiring supportive treatment; Sinais and/or symptoms of the severe cardiac form of Doença de Chagas; History of cardiomyopathy, heart failure, or severe ventricular arrhythmia of any etiology; Participation in another clinical trial in the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected therapeutic efficacy assessed from the parasitological response defined as sustained elimination of the parasite in 10 months of follow-up after or treatment determined by serial qualitative PCR results | — |
Secondary
| Measure | Time frame |
|---|---|
| To analyze the efficacy of treatment with Benznidazole at a dose of 300 mg/day for 8 weeks based on the genotyping of T. cruzi;To compare the safety of Benznidazole at a dose of 300 mg/day for 8 weeks in comparison with NFX at a dose of 600mg/day for 8 weeks without treatment of Chagas disease in the chronic phase in its indeterminate or mild cardiac forms;To assess parasitic kinetics by detecting parasitic DNA measured by qualitative PCR in peripheral blood at 4, 6, 8 and 12 months after the start of treatment in participants with chronic Chagas disease, in its indeterminate or mild cardiac forms treated with each um two or two therapeutic regimens;To measure longitudinal changes in the quality of life of two participants with Chagas disease in the chronic phase in its indeterminate or mild cardiac forms treated with each of two therapeutic regimens through two WHOQoL-BREF and EQ-5D-3 questionnaires;The frequency of adverse events that lead to discontinuation of treatment is expected to be evaluated.;To compare the efficacy of Benznidazole based on the geographic origin of the participant versus Nifurtimox | — |
Countries
Brazil
Contacts
Public ContactCarla Renata Trevia
Instituto Nacional de Infectologia Evandro Chagas
Outcome results
None listed