Chagas Disease Clinical Trial
Official title:
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.
n/a
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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