Evaluation of the efficacy and safety of Artemether +Lumefantrine (Coartem®) with low-dose Primaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in three sites of Savanakhet, Salavanh, and Attopue province, Lao PDR (2022)

Evaluation of the efficacy and safety of Artemether+ Lumefantrine (Coartem®) with low-dose Primaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in three sites of Savanakhet, Salavanh, and Attopue province, Lao PDR. To assess the efficacy of current first line treatment policy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum and P. vivax malaria infections. Study Sites: Three provinces of Savanakhet (5 districts of Phin, Sepon, Nong, Vilabury, and Thapangtong), Salavanh (2 provincial hospitals (public and Military) and 3 districts of Samouai, Taoi and Toumlan), and Attopue (4 districts of Phouvong, Sansay, Sanamsay, and Saysetha; and 1 Military hospital) Study Period: From August 2022 to September 2023 Study Design: This surveillance study is a one arm prospective study Patient population: Febrile patients aged between 6 months and 60, with confirmed uncomplicated P. falciparum and P. vivax infection, except females aged 12-18 years old, as it is culturally sensitive to request pregnancy test for young unmarried women. Sample Size: Total of 300 patients to be enrolled 150 P.falciparum and 150 P.vivax cases. Each study site/province will recruit 100 cases, in which 50 cases maximum of P.falciparum and 50 cases maximum of P.vivax) Treatment(s) and follow-up: Artemether-lumefantrine drug combination (Artemether 20mg / lumefantrine 120 mg per tablet), twice a day will be administered over 3 days according to body weight to a total of 6 doses. Primaquine will be administered as a single 15-mg adult dose (0.25 mg base/kg) on day 0 for uncomplicated P. falciparum cases, and once daily (0.25 base/kg) for 14 days for G6PD normal or weekly dose (0.75 base/kg) for 8 weeks for G6PD deficient P. vivax cases. The correct drug dosage will be determined from the dosing chart . Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Secondary endpoints: The frequency and nature of adverse events Exploratory endpoints: to determine the polymorphism of molecular markers for artemisinin resistance.