Ethiopian Antimalarial Therapeutic Efficacy Study 2026

Inclusion criteria

• 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.
• Body weight ≥5.0 kg.
• Hemoglobin (Hb) concentration ≥ 8 g/dL.
• Ability to swallow oral medication.
• Ability and willingness (or that of a parent/legal guardian for children) to comply with the study protocol and scheduled follow-up visits.
• Provision of written informed consent by the participant or a parent/legal guardian for minors. Where applicable, assent will be obtained from older children in accordance with national ethical requirements.
• Willingness of women of reproductive age (12-49 years) to take a pregnancy test

Exclusion criteria

• 1. Presence of signs or symptoms of severe malaria or danger signs suggestive of severe malaria, as defined by the WHO (Annex I).

• Severe malnutrition, defined as any of the following: weight-for-height or weight-for-age according to national/WHO criteria, bilateral pitting edema of nutritional origin, or mid-upper arm circumference (MUAC) <11.5 cm for children aged 6-59 months 3. Mixed Plasmodium species infection. 4. Moderate to severe anemia (hemoglobin <8 g/dL) 5. Presence of febrile illness due to causes other than malaria requiring alternative treatment (e.g., measles, acute lower respiratory tract infection, or severe diarrhea with dehydration).

• Presence of a serious or chronic medical condition that may interfere with study participation or outcome assessment (e.g., cardiac, renal, hepatic disease, sickle cell disease, or HIV/AIDS).

• Known pregnancy or pregnancy test positive or breastfeeding. 8. Women of childbearing potential who are unwilling or unable to use effective contraception during the study period, where applicable according to the study drug requirements.

• Known hypersensitivity or allergy to the study medication or any alternative antimalarial treatment used in the study.

• Current use of medications known to interfere with the pharmacokinetics, efficacy, or safety of the study antimalarial drugs (Annex II).