Population Pharmacokinetics 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.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Population Pharmacokinetics Study of Benznidazole in Children With Chagas Disease|
- 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 ]
- Adverse events [ Time Frame: 2 months (treatment period) ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Treatment of pediatric Chagas disease with benznidazole
benznidazole (RADANIL®, Roche) 5-8 mg/kg/d bid PO for 60 days
|Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires|
|Buenos Aires, Argentina, 1425|
|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|