drugset / Trial / NCT01549236
Population Pharmacokinetics Study of Benznidazole in Children With Chagas'Disease
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to describe the population pharmacokinetics parameters of benznidazole in children with acute or early chronic indeterminate form of Chagas Disease.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-08
- Completion
- 2012-10
Publications
- Background Andrade AL, Martelli CM, Oliveira RM, Silva SA, Aires AI, Soussumi LM, Covas DT, Silva LS, Andrade JG, Travassos LR, Almeida IC. Short report: benznidazole efficacy among Trypanosoma cruzi-infected adolescents after a six-year follow-up. Am J Trop Med Hyg. 2004 Nov;71(5):594-7.
- Background de Andrade AL, Zicker F, de Oliveira RM, Almeida Silva S, Luquetti A, Travassos LR, Almeida IC, de Andrade SS, de Andrade JG, Martelli CM. Randomised trial of efficacy of benznidazole in treatment of early Trypanosoma cruzi infection. Lancet. 1996 Nov 23;348(9039):1407-13. doi: 10.1016/s0140-6736(96)04128-1.
- Background Sosa-Estani S, Segura EL. Etiological treatment in patients infected by Trypanosoma cruzi: experiences in Argentina. Curr Opin Infect Dis. 2006 Dec;19(6):583-7. doi: 10.1097/01.qco.0000247592.21295.a5.
- Background Ribeiro I, Sevcsik AM, Alves F, Diap G, Don R, Harhay MO, Chang S, Pecoul B. New, improved treatments for Chagas disease: from the R&D pipeline to the patients. PLoS Negl Trop Dis. 2009 Jul 7;3(7):e484. doi: 10.1371/journal.pntd.0000484. No abstract available.
- Background Garcia-Bournissen F, Altcheh J, Giglio N, Mastrantonio G, Della Vedova CO, Koren G. Pediatric clinical pharmacology studies in Chagas disease: focus on Argentina. Paediatr Drugs. 2009;11(1):33-7. doi: 10.2165/0148581-200911010-00012.
- Altcheh J, Moscatelli G, Caruso M, Moroni S, Bisio M, Miranda MR, Monla C, Vaina M, Valdez M, Moran L, Ramirez T, Patino OL, Riarte A, Gonzalez N, Fernandes J, Alves F, Ribeiro I, Garcia-Bournissen F. Population pharmacokinetics of benznidazole in neonates, infants and children using a new pediatric formulation. PLoS Negl Trop Dis. 2023 May 31;17(5):e0010850. doi: 10.1371/journal.pntd.0010850. eCollection 2023 May.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benznidazole | Small molecule | 7.5 mg/kg | Oral |