Last Updated: 10/06/2024
A multi-center, open-label, randomized, comparative phase iii trial to evaluate efficacy and safety of dihidroartemisinin-piperaquine versus chloroquine for uncomplicated malaria by plasmodium vivax monoinfection
Objectives
*Original in Portuguese: Um estudo multicêntrico, de fase iii, aberto, randomizado e comparativo para avaliar eficácia e segurança de dihidroartemisinina-piperaquina versus cloroquina para malária não complicada por monoinfecção de Plasmodium vivax
This study will compare the efficacy and safety of the fixed dose combination of dihidroartemisin plus piperaquine (DHA-PQP) with chloroquine in the treatment of uncomplicated vivax malaria, with the main objective of demonstrating the superiority of the parasitological response of Dihydroartemisinin + Piperaquine (Eurartesim® ) versus Chloroquine and to evaluate the failure rate for 180 days, considering different days of introduction of primaquine at the dose of 0.50 mg base kg / day for 14 days. days (total duplicate dose).
Doctor Heitor Vieira Dourado Foundation for Tropical Medicine (FMT-HVD), Brazil
Human malaria by Plasmodium vivax is the most widespread, putting 2.5 billion people at risk of infection, and can progress to severe cases. Resistance to chloroquine is now a major obstacle to the elimination of malaria. With a superiority margin (Δ) chosen at 5%, α / 2 = 2.5% and β = 10%, and the hypothesis of 90% success with QC and the 95% success hypothesis with DHA-PQP, 100 patients per treatment group are requested (Nquery advisor, process PTE1a-1); Taking into account 15% loss of follow-up, 171 patients are needed per treatment group. Considering a 10% risk of mixed infections, a total of 460 patients older than six months of age, with mono-infection confirmed by Plasmodium vivax will be included. Eligible patients will be randomly assigned to receive either DHA-PQP or chloroquine for 3 days according to the primaquine-adjusted regimen, which will be given as anti-relapse therapy on day 1 or day 42 and continued for 14 consecutive days (total 7 mg base / kg / day). The primary efficacy analysis will include the assessment of the proportion of patients with aphasitis in 72 hours. Safety outcomes will be analysis of adverse events, vital signs, laboratory data and abnormalities on the electrocardiograph. Patients will participate in the study for 180 days with the primary endpoint at day 42. To demonstrate the superiority of DHA-PQP compared to chloroquine, the 95% confidence interval of the observed difference between the two treatment success rates will be determined. The observed difference Δ in the success rate between the two treatment groups should not exceed -5%. Non-inferiority will be demonstrated if the lower limit of the 95% CI is greater than -0.05 for a unilateral risk of 2.5% (/ 2). In addition, understanding the mechanisms of decreased therapeutic response or increased adverse reactions, we hope to contribute to the individualization of malaria treatment by helping to select the best alternative drug, such as DHA-PQP.
Oct 2018 — Oct 2021
