Population Pharmacokinetics of Benznidazole in Children With Chagas Disease

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
The Hospital for Sick Children
Fundacion Bunge y Born (Argentina)
Universidad Nacional de La Plata
Consejo de Investigacion en Salud Gobierno de Buenos Aires
Information provided by:
Hospital de Niños R. Gutierrez de Buenos Aires
ClinicalTrials.gov Identifier:
NCT00699387
First received: June 16, 2008
Last updated: July 29, 2011
Last verified: July 2011

June 16, 2008
July 29, 2011
April 2007
May 2011   (final data collection date for primary outcome measure)
Description of Population pharmacokinetics parameters of benznidazole (i.e. median population clearance, absorption and volume of distribution, and their respective inter-individual variabilities) [ Time Frame: 2 months (treatment period) ] [ Designated as safety issue: No ]
Population pharmacokinetics of benznidazole [ Time Frame: 2 months (treatment period) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00699387 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: 2 months (treatment period) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Population Pharmacokinetics of Benznidazole in Children With Chagas Disease
Population Pharmacokinetics Study of Benznidazole in Children With Chagas Disease

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 develop chronic infection leading to heart disease and other complications in 30% of patients. These complications often result in death or severe handicaps in early adulthood, depriving societies of individuals in their most productive years.

There are 20 million people infected in Latin America. Complications lead to 20,000 deaths every year.

Treatment during the acute phase with benznidazole leads to a high cure rate. However, there are very few studies of this drug and virtually none in children, even though benznidazole was developed over 30 years ago.

Hypotheses and Specific Aims: We hypothesize that the pharmacokinetics of benznidazole in children is different from adults, and that obtaining information on how it is absorbed, distributed and eliminated in children will allow optimization of treatment of Chagas disease in this population. This will in turn improve the outlook for children by reducing mortality and long term complications. We aim to study the pharmacokinetics of benznidazole in children receiving the drug for treatment of Chagas disease, and to correlate it with treatment effectiveness and incidence of adverse effects.

Potential Impact: This novel knowledge will allow better and more rational approaches to the treatment of Chagas disease. It will also set the foundation for further studies that will be able to test improved therapies that may increase treatment response in vulnerable children.

Not Provided
Interventional
Not Provided
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Chagas Disease
Drug: Benznidazole
benznidazole (RADANIL®, Roche) 5-8 mg/kg/d bid PO for 60 days
Other Names:
  • Children with Chagas Disease Treated with Benznidazole
  • Niños con Chagas en Tratamiento con Benznidazol
Experimental: Benznidazole
Treatment of pediatric Chagas disease with benznidazole
Intervention: Drug: Benznidazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
2 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00699387
CHAGAS-CHILDREN-POPPK
Yes
Dr Jaime Altcheh, Servicio de Parasitología, Hospital de Niños "R Gutiérrez" de Buenos Aires
Hospital de Niños R. Gutierrez de Buenos Aires
  • Thrasher Research Fund
  • The Hospital for Sick Children
  • Fundacion Bunge y Born (Argentina)
  • Universidad Nacional de La Plata
  • Consejo de Investigacion en Salud Gobierno de Buenos Aires
Study Director: Jaime Altcheh, MD Parasitology Service, Children's Hospital "R. Gutierrez" of Buenos Aires
Principal Investigator: Facundo Garcia Bournissen, MD Division of Clinical Pharmacology & Toxicology, Hospital for Sick Children, University of Toronto
Principal Investigator: Norberto Giglio, MD Epidemiology Service, Children's Hospital "R. Gutierrez" of Buenos Aires
Principal Investigator: Gideon Koren, MD Division of Clinical Pharmacology &Toxicology, Hospital for Sick Children, University of Toronto
Principal Investigator: Oscar Della Vedova Universidad Nacional de La Plata
Principal Investigator: Guido Mastrantonio Facultad de Ciencias Exactas, Universidad Nacional de La Plata
Hospital de Niños R. Gutierrez de Buenos Aires
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP