Chagas Disease
Conditions
Interventions
Uncontrolled, unmasked single-center study with a single group.
Patients with chronic CD in the indeterminate form regularly treated at the outpatient clinic of the Clinical Research Laboratory in Cha
Sponsors
Fundação Oswaldo Cruz
Fundação Oswaldo Cruz
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Adult patients with Chagas disease indeterminate form of both sexes, aged between 18 and 70 years old.
Exclusion criteria
Exclusion criteria: Patients with a history of previous treatment with benznidazol (BZ), contraindications or hypersensitivity to the use of BZ, renal or hepatic failure, gastrointestinal disorders or other condition that interferes with the processes of absorption, distribution, excretion or metabolism of the drug, pulmonary, epileptic, hematological or psychiatric, pregnancy or lactation, associated heart disease such as moderate or severe orovalvular disease, ischemic, congenital or hypertensive heart disease, comorbidities such as malignant tumors and HIV infection, cognitive limitation that does not allow the correct understanding of the IC and the stages of the project, individuals participating in other investigations with interventions, using three or more medications of regular use within the 02 weeks prior to the start of the study treatment, except contraceptives (for women), omeprazole and simvastatin, or any eventual medication within 07 days before the start of study treatment, except dipyrone and paracetam ol, with a history of treatment within the 3 months prior to the study with any drug with known toxic potential in large organs. Participants with a history of loss or donation of 450 mL or more of blood within the three months prior to the scheduled visit date will also be excluded.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 20% increase for Benznidazole pharmacokinetic parameters Cmax, T1/2 and AUC0-t, between age and sex profiles;To evaluate the correlation between the occurrence of adverse events and pharmacokinetic parameters in patients with chronic Chagas disease with indeterminate form treated with benznidazol for a period of 60 days | — |
Primary
| Measure | Time frame |
|---|---|
| Determine the steady-state pharmacokinetics of benznidazol after 15 days of treatment in patients with chronic CD with indeterminate form. | — |
Countries
Brazil
Contacts
Public ContactRoberto Saraiva
Outcome results
None listed