Chagas Disease
Conditions
Brief summary
o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.
Interventions
DRUGBenznidazole
Sponsors
Barcelona Centre for International Health Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with Chronic Chagas Disease diagnosed by 2 different and positive serological tests. * Patients with Chronic Chagas Disease who are going to start treatment with Benznidazole. * Any gender. * All the participants must agree to participate in the study and must sign the informed consent.
Exclusion criteria
* Patients younger than 18. * Patients with previous hypersensitivity to Benznidazole. * Immunocompromised patients as AIDS, cancer, chemotherapy, longterm corticoids need, primary immunodeficiency, or any other. * Hepatic dysfunction * Renal dysfunction: serum creatinin higher than 3 mg/dl. * Pregnancy or lactation. * Low adhesion to treatment or check-up. * Impossibility of follow-up. * Severe adverse reaction to Benznidazole. * Any other situation that could be risky for the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Population pharmacokinetic parameters of Benznidazole | 2 months (treatment period) | Population pharmacokinetic model development |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions | 2 months (treatment period) | Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration. |
Countries
Spain
Outcome results
None listed