Efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for the treatment of uncomplicated Plasmodium vivax malaria in Binh Phuoc, Gia Lai and Phu Yen provinces, Viet Nam in 2021.

The guidelines for malaria diagnosis and treatment in Vietnam was revised and issued in June 2020. Malaria diagnois and treatment are being provided free of charge in Vietnam. First line treatment of falciparum malaria is dihydroartemisinin-piperaquine (DHA-PIP) or artesunate-pyronaridine.We here propose an open-labelled clinical trial to assess the efficacy and safety of artesunate -pyronaridine for the treatment of uncomplicated falciparum malaria in Binh Phuoc, Gia Lai and Phu Yen in Viet Nam, where were confirmed dihydroartemisinin - piperaquine resistance Interventional study for the assessment of drug efficacy and safety over 42 days Patients with acute uncomplicated P. falciparum malaria. Samples size: 42 patients. One tablet contains 60 mg of artesunate and 180 mg of pyronaridine 3-day regimen Dosing will be according to body weight. All patients will have a blood smear examined every 24 hours from D0 – D3 or during the first week by microscopy until parasite clearance. The primary endpoint of the study is day 42 PCR corrected ACPR ( Adequate clinical and parasitological response). The secondary endpoints • The numbers of patients with a positive malaria slide 72 hours after treatment initiation • Fever clearance time and parasite clearance time. • Kaplan Meier analysis over 42 days for recrudescence and reinfections. • Documented AEs and SAEs and relationships to study drugs. P. vivax-infected patients will be given Chloroquine for 3 days and monitored clinically and parasitically for 28 days after taking the drug. Chloroquine tablets containing 150 mg of chloroquine base, all patients will be received a full treatment dose of 25 mg of chloroquine base per kg given over 3 days. Primaquine will be given after Day 28. Chloroquine tablets are made in Vietnam.