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) - Trial ANZCTR12623000241639

Timeline & Enrollment

Primary Outcome

All 3 primary outcomes such as "The proportion of patients with early treatment failure'; "late clinical failure"; and "late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy" will be assessed as a composite primary outcomes, not assess independently. These outcome will be assessed under appointment of regular clinical and parasitological re-assessment, which focus on temperature check for any fever detection then blood films will be made for apprearance, density of parasites, and collection of blood as dry blood spot (DBS) for further PCF and molecular mapping, especially on day, 2, 3, 7 then weekly for remainder of the follow-up period. Patients will be advised to return on any days during the follow-up period if symptoms return and not to wait for the next schedule visit day. The DBS will be collected on D0 (and day of faillure) to study the polymorphism or copy mubers of Pfmdr1, pfatp6, and pfcrt gene, which are considered as marker of resistance to artemether -Lumefantrine. The technique used will be polymerase chain reation (PCR).the test will be done at the WHO reference laboratory of Pasteur Institute, Cambodia.

Summary

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.

ICD-10 Classifications