Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease (CINEBENZ)

Barcelona Centre for International Health Research

Status and phase

Completed

Phase 4

Conditions

Chagas Disease

Treatments

Drug: Benznidazole

Study type

Interventional

Funder types

Other

Identifiers

CINEBENZ

Details and patient eligibility

About

o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.

Enrollment

52 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.