Study of the variabiliy in dose-concentration correlation of Benznidazol in adult patients with Chronic Chagas Disease and the relationship between drug pharmacokinetics and adverse reactions.

Conditions: The study will be held in 50 patients with Chronic Chagas Disease.
MedDRA version: 14.1Level: LLTClassification code 10008384Term: Chagas' diseaseSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

Registration Number: EUCTR2011-002900-34-ES

Lead Sponsor: CRESIB- International Research Center in Health of Barcelona

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 Benznidazol.
- Any gender.
- All the participants must agree to participate in the study and must sign the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients yonger than 18.
- Patients with previous hipersensitivity to Benznidazol.
- Inmunocompromised patients as AIDS, cancer, chemoterapy, long-term corticoids need, primary inmunodeficiency, or any other.
- Hepatic dysfunction
- Renal dysfunction: serum creatinin higher than 3 mg/dl.
- Pregnancy or lactation.
- Low adhesion to treatment or check-up.
- Imposibility of follow-up.
- Severe adverse reaction to Benznidazol.
- Any other situation that could be risky for the patient.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study population pharmacokinetics in Benznidazol-treated adult patients with Chronic Chagas Disease to get information to optimaze drug doses.;Secondary Objective: 1. To find relationship between Benznidazol pharmacokinetics and other different factors as demographic factors (age, weight, gender), biochemical factors (renal function, hepatic function) or physiopatological factors (adverse reactions), to try to understand drug's interindividual variability.<br>2. To find if there is any relationship between drug's serum concentration and adverse reactions.;Primary end point(s): There is no study held before this one where Benznidazol's population pharmacokinetics have being analyzed, so this will be a pioneering<br>study. Because of that all the results will be collected.;Timepoint(s) of evaluation of this end point: Asuming the recruitment and treatment periods, about 18 month will be needed.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To analyze if there is a relationship between Banznidazol's plasma concentration and the seriousness o frecuency of adverse reactions.;Timepoint(s) of evaluation of this end point: Asuming the recruitment and treatment periods, about 18 month will be needed.