Population Pharmacokinetics of Benznidazole in Children With Chagas Disease
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
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 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.
Phase:
N/A
Details
Lead Sponsor:
Hospital de Niños R. Gutierrez de Buenos Aires
Collaborators:
Consejo de Investigacion en Salud Gobierno de Buenos Aires Fundacion Bunge y Born (Argentina) The Hospital for Sick Children Thrasher Research Fund Universidad Nacional de La Plata