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Last Updated: 16/06/2024
Phase IIb study to evaluate the safety and tolerability of primaquin for the radical cure of uncomplicated malaria caused by Plasmodium vivax in children <15 years of age (CHILDPRIM)
Objectives
*Original title in Portuguese: Estudo de fase IIb para avaliação de segurança e tolerabilidade da primaquina para a cura radical da malária não complicada causada por Plasmodium vivax em crianças <15 anos de idade (CHILDPRIM)
The CHILDPRIM study intends to carry out a safety study of the use of primaquine in different regimens in children <15 years of age.
Worldwide, although primaquine is recommended for the radical treatment of P. vivax malaria in children over 6 months of age, there are few studies that have evaluated the safety of this drug in this vulnerable population, which still represents ~30% of malaria cases in the Brazilian Amazon. In Brazil, the dose of primaquine recommended by the Ministry of Health is 0.5mg/kg/day for 7 days, a different regimen than that usually recommended by the World Health Organization (0.25mg/kg/day for 14 days). Nor has the scheme recommended by the CDC been evaluated in the pediatric range (0.5mg/kg/day for 14 days). This will allow the safer adoption of this medication, which is still decisive for the radical treatment and eventual elimination of vivax malaria, considering that the registration of tafenoquine in this population is not yet a reality.
Jan 2021
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