Last Updated: 30/10/2025
An Open Label Randomized Comparative Study to assess the efficacy and tolerability of Eurartesim® versus Chloroquine and nonrelapse therapy with Primaquine for uncomplicated Plasmodium Vivax monoinfection malaria
Objectives
To demonstrate the superiority of the parasitological response on day 42 of dihydroartemisinin plus piperaquine (DHA-PQP or Eurartesim®) versus chloroquine, and to evaluate the proportion of failures up to day 180, considering different days of introduction of primaquine at a dose of 0.50 mg/kg/day for 14 days.
Doctor Heitor Vieira Dourado Foundation for Tropical Medicine (FMT-HVD), Brazil
Ministry of Health (MOH) Brazil
Oswaldo Cruz Foundation (Fiocruz), Brazil
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. 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.
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
ClinicalTrials.gov Identifier: NCT03208907
Jul 2018 — Jul 2021
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