An interventional study of Benznidazole in Chagas Disease, sponsored by Hospital de Niños R. Gutierrez de Buenos Aires. Completed at 1 site in Argentina. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2011-08-01.
Sponsored by Hospital de Niños R. Gutierrez de Buenos Aires · Not applicable, Interventional, and Basic science
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.
68 studies on the registry are indexed under Chagas Disease; 4 are open to participants now.
This study's enrollment of 37 is below the median of 87 across 45 interventional studies indexed under Chagas Disease.
Browse Chagas Disease studies →Hospital de Niños R. Gutierrez de Buenos Aires is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment of pediatric Chagas disease with benznidazole
Drug: Benznidazole
benznidazole (RADANIL®, Roche) 5-8 mg/kg/d bid PO for 60 days
Also known as: Children with Chagas Disease Treated with Benznidazole, Niños con Chagas en Tratamiento con Benznidazol
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)
Adverse events
Time frame: 2 months (treatment period)
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Hospital de Niños R. Gutierrez de Buenos Aires