Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease

Barcelona Centre for International Health Research52 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chagas Disease

Interventions

BenznidazoleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

International Health Department, Hospital Clinic, Barcelona

Barcelona, Catalonia, Spain

Outcomes

Primary Outcomes

Population pharmacokinetic parameters of Benznidazole

Population pharmacokinetic model development

Time frame: 2 months (treatment period)

Secondary Outcomes

Adverse reactions

Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration.

Time frame: 2 months (treatment period)

Data from ClinicalTrials.gov

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