DHA-PQP vs Chloroquine and Primaquine for Radical Cure of Vivax Malaria in Brazil

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 are initially planned to 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.

Timeline

Start

2018-07-05

Primary completion

2021-07-02

Completion

2021-07-02

Publications

• Baia-da-Silva DC, Machado KVA, Rabelo ALR, da Silva Balieiro AA, Barbosa ASL, Costa MRF, Sampaio VS, Melo GC, Alexandre MAA, Alencar ACC, Nascimento CT, Jeronimo CMP, Marcovski MS, Barbosa LRA, Valle CS, Carrilho TAA, Vieira JLF, de Melo MM, Dinelly KMO, Omena AG, Brito-Sousa JD, Barreiros GA, Rocha YV, Filho ACA, Bassat Q, Alecrim MDGC, Siqueira AM, Lacerda MVG. Dihydroartemisinin-piperaquine versus chloroquine for the treatment of uncomplicated Plasmodium vivax malaria with concurrent or delayed high-dose primaquine in Brazil (Curavivax): an open-label, single-centre, randomised clinical trial. Lancet Infect Dis. 2026 May 11:S1473-3099(26)00139-8. doi: 10.1016/S1473-3099(26)00139-8. Online ahead of print.

Drugs

Indications