Status:
COMPLETED
Population Pharmacokinetics of Benznidazole in Children With Chagas Disease
Lead Sponsor:
Hospital de Niños R. Gutierrez de Buenos Aires
Collaborating Sponsors:
Thrasher Research Fund
The Hospital for Sick Children
Conditions:
Chagas Disease
Eligibility:
All Genders
2-12 years
Phase:
NA
Brief Summary
Background: Chagas disease is a parasitic infection caused by the Trypanosome cruzi. The initial phase of the infection happens mainly in children. Up to 10% of infected children die. Survivors often ...
Eligibility Criteria
Inclusion
- Children 2 - 12 years old of both sexes, with a diagnosis of Chagas' disease and eligible for treatment with benznidazole, as per current treatment protocols.
- Chagas disease diagnostic criteria: At least 2 positive serological tests for Trypanosoma cruzi infection (ELISA, hemoagglutination, particle agglutination tests).
- Informed consent signed by the parents, and consent or assent of the patients (according to age and consenting capacity).
Exclusion
- Patients with a history of hypersensitivity to benznidazole or any of the drug excipients
- Immunocompromised patients
- Altered hepatic function (increase in AST/ALT x3 or bilirubin x3) or altered renal function (increase in creatinine x3)
- Pregnancy
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00699387
Start Date
April 1 2007
End Date
May 1 2011
Last Update
August 1 2011
Active Locations (1)
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1
Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Buenos Aires, Buenos Aires, Argentina, 1425