The study will be held in 50 patients with Chronic Chagas Disease. MedDRA version: 14.1 Level: LLT Classification code 10008384 Term: Chagas' disease System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
CRESIB- International Research Center in Health of Barcelona
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Contacts
Public ContactCRESIB
CRESIB-International Research Center in Health of Barcelona
Outcome results
None listed