DHA-PQP vs Chloroquine and Primaquine for Radical Cure of Vivax Malaria in Brazil
Status:
Active, not recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
Plasmodium vivax can be cause of severe malaria and mortality. There are serious public
health implications associated with cases of P. vivax resistant to Chloroquine in the
Americas as well there are efforts of many countries to eliminate this disease. In this way,
it is critically important to evaluate an alternative radical cure treatment efficient to
amazon scenario. The objectives of this trial are to demonstrate the superiority of adequate
parasitological response at D42 of Dihydroartemisinin plus Piperaquine (DHA-PQP or
Eurartesim®) versus Chloroquine and to evaluate the proportion of failure until D180
considering different starting days of Primaquine (0.50 mg/kg/day) for 14 days. It is an
open, 4 arms, randomised, comparative trial. Total of 460 patients must be included. To
demonstrate the superiority of DHA-PQP compared to Chloroquine, the 95% confidence interval
of the difference observed between both treatment success rates will be determined. Each
recurrence will be passively and actively detected for 180 days.
Phase:
Phase 3
Details
Lead Sponsor:
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Collaborators:
Ministry of Health, Brazil Oswaldo Cruz Foundation