Background: The WHO recommends monitoring the efficacy of antimalarial drugs at least once every two years after implementation. The Ethiopian Public Health Institute (EPHI), the research arm for the Ministry of Health (MOH), has been studying the safety and efficacy of antimalarial drugs for the past two decades. The national malaria diagnosis and treatment guideline of Ethiopia states first-line treatment for uncomplicated Plasmodium falciparum (P. falciparum) infection is artemether-lumefantrine (AL) with a single dose of primaquine (PQ) and for uncomplicated P. vivax infection chloroquine (CQ) with 14 days of PQ. This study aimed to evaluate the therapeutic efficacy of AL plus a single low dose of PQ for uncomplicated P. falciparum malaria and CQ plus 14 days of PQ for uncomplicated P. vivax malaria in six sentinel sites of Ethiopia.
Methods: This study will be conducted from October 2026 to June 2027 in six sentinel sites. A minimum of 100 patients each with uncomplicated P. falciparum or P. vivax malaria aged 6 months and above, will be enrolled at each of the six study sites and followed for 28 days for P. falciparum and 42 days for P. vivax for adequate clinical and parasitological response. Patients with microscopically confirmed P. falciparum mono-infection will be assigned to receive AL + PQ, and those with microscopically confirmed P. vivax mono-infection will be assigned to receive CQ + PQ. Clinical, parasitological, and hematologic parameters will be monitored for P. falciparum and P. vivax infections for up to a 28/42-day follow-up period and used to evaluate drug efficacy. Kaplan-Meier method survival analysis and pertinent descriptive analysis will be conducted using STATA considering P \< 0.05 as statistically significant. Results from this research will be presented in text narration, tables and figures.
Patients aged ≥ 6 months.
Microscopically confirmed uncomplicated P. falciparum mono-infection with an asexual parasite density of 1000-100,000 parasites/µL, or an uncomplicated P. vivax mono-infection with an asexual parasite density of 250-100,000 parasites/µL.
Presence of fever (axillary temperature ≥37.5°C) or a history of fever during the preceding 24 hours.
Residence within 20 km of the enrolling health facility (or within the defined study catchment area) and willingness to remain in the area for the duration of follow-up.
1. Presence of signs or symptoms of severe malaria or danger signs suggestive of severe malaria, as defined by the WHO (Annex I).
The study population will consist of patients residing in malaria-endemic areas who self-present to the outpatient departments of the selected health facilities with uncomplicated P. falciparum or P. vivax malaria. Only patients living within the catchment area of the participating health facilities (within a 20 km radius) will be eligible for enrollment. This geographical restriction is intended to facilitate active follow-up through home visits for participants who fail to attend their scheduled follow-up visits, thereby minimizing loss to follow-up and ensuring complete outcome assessment.
Case-only
Prospective
Artemether-Lumefantrine + Primaquine and Chloroquine + Primaquine
DrugFor uncomplicated P. falciparum patients, 3 days of a bid dose of Artemether-lumefantrine with a single low dose of primaquine. For uncomplicated P. vivax patients, 3 days dose of chloroquine with 14 days primaquine will be given under observation
Early Treatment Failure
1\. Danger signs or severe malaria on day 1, day 2 or day 3 in the presence of parasitemia; or 2. Parasitemia on day 2 higher than on day 0, irrespective of axillary temperature; or 3. Parasitemia on day 3 with axillary temperature ≥37.5 ºC; or 4. Parasitemia on day 3 ≥25% of count on day 0.);
Late Clinical Failure
1\. Danger signs or severe malaria in the presence of parasitemia on any day between day 4 and 28 for P.f or day 42 for P.v in patients who did not previously meet any of the criteria of Early Treatment Failure; or 2. Presence of parasitemia on any day between 4 and day 28 (day 42) with axillary temperature ≥37.5 ºC (or history of fever) in patients who did not previously meet any of the criteria of early treatment failure
Late Parasitological Failure
Presence of parasitemia on any day between Day 7 and Day 28 for P.f or Day 42 for P.v and axillary temperature \<37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure.
Adequate Clinical and Parasitological Response
Adequate clinical and parasitological response during 28 days of follow-up for P. falciparum and 42 days of P. vivax. It is the absence of parasitemia on Day 28 for P.f or Day 42 for P.v irrespective of axillary temperature in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure, or late parasitological failure.
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Ethiopian Public Health Institute
Lead sponsor
PATH
Collaborator
US government
Collaborator
National Centre for Disease Prevention and Control
Collaborator
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