Plasmodium Vivax Malaria Without ComplicationTES2026NCT07840898
Ethiopian Antimalarial Therapeutic Efficacy Study 2026
An observational study of Plasmodium Vivax Malaria Without Complication and Plasmodium Falciparum Malaria (Uncomplicated), run by Ethiopian Public Health Institute at 1 site in Ethiopia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Plasmodium Vivax Malaria Without Complication, Plasmodium Falciparum Malaria (Uncomplicated)
- What is being tested?
- Artemether-Lumefantrine + Primaquine and Chloroquine + Primaquine
- How many people
- 1,200 participants
- Where
- 1 siteEthiopia
- Study dates
- 20 Oct 2026to 30 Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 1. Presence of signs or symptoms of severe malaria or danger signs suggestive of severe malaria, as defined by the WHO (Annex I).
- 2. 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).
- 6. 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).
- 7. 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.
- 9. Known hypersensitivity or allergy to the study medication or any alternative antimalarial treatment used in the study.
- 10. Current use of medications known to interfere with the pharmacokinetics, efficacy, or safety of the study antimalarial drugs (Annex II).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site
Ethiopian Public Health Institute
Addis Ababa
Bokretsion G Brhane, MSc, +251931571838, bokregidey@yahoo.com
About this study
Official title: Therapeutic Efficacy and Safety of Artemether-Lumefantrine Plus Primaquine for Uncomplicated Plasmodium Falciparum Malaria and Chloroquine Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria in Ethiopia: A Multi-center, Open-label Observational Study
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.
- Conditions
- Plasmodium Vivax Malaria Without Complication, Plasmodium Falciparum Malaria (Uncomplicated)
- Being tested
- Artemether-Lumefantrine + Primaquine and Chloroquine + Primaquine
- Keywords
- P. falciparum; P. vivax; Therapeutic Efficacy; Ethiopia
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-Lumefantrine + Primaquine and Chloroquine + PrimaquineDrug
For 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Treatment Failure
- 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.);
Measured: Day 1 to Day 3
Late Clinical Failure
- 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
Measured: Between Day 4 and 28 for P.f and Day 42 for P.v
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.
Measured: Between Day 7 and Day 28 for P.f or Day 42 for P.v
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.
Measured: Day 28 for P.f or Day 42 for P.v
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasmodium Vivax Malaria Without ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ethiopian Public Health Institute
- Sponsor type
- Other government
- Collaborators
- PATH, US government, National Centre for Disease Prevention and Control
- Responsible party
- Principal investigator, Bokretsion Gidey, Ethiopian Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840898
- Sponsor's protocol ID
- EPHI-IRB-688-2026
- Acronym
- TES2026
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1. WHO. World malaria report 2025. Geneva: World Health Organization; 2025. 2. Ministry of Health. National Malaria Elimination Strategic Plan: 2021-2025. Addis Ababa: Ethiopia Ministry of Health; 2020. 3. PMI. U.S. President's Malaria Initiative Ethiopia Malaria Operational Plan FY 2024.: President's Malaria Initiative; 2024. 4. WHO. Guidelines for the Treatment of Malaria. Geneva: World Health Organization; 2015. 5. WHO. WHO guidelines for malaria. Geneva: World Health Organization; 2025. 6. White NJ. Antimalarial drug resistance. J Clin Invest. 2004;113(8):1084-92. 7. Talisuna AO, Bloland P, D'Alessandro U. History, dynamics, and public health importance of malaria parasite resistance. Clin Microbiol Rev. 2004;17(1):235-54. 8. Bloland PB, Kazembe PN, Oloo AJ, Himonga B, Barat LM, Ruebush TK. Chloroquine in Africa: critical assessment and recommendations for monitoring and evaluating chloroquine therapy efficacy in sub-Saharan Africa. Trop Med Int Health. 1998;3(7):543-52. 9. Trape JF, Pison G, Preziosi MP, Enel C, Desgrees du Lou A, Delaunay V, et al. Impact of chloroquine resistance on malaria mortality. C R Acad Sci III. 1998;321(8):689-97. 10. Laxminarayan R. Act now or later? Economics of malaria resistance. The American journal of tropical medicine and hygiene. 2004;71(2 Suppl):187-95. 11. Nosten F, van Vugt M, Price R, Luxemburger C, Thway KL, Brockman A, et al. Effects of artesunate-mefloquine combination on incidence of Plasmodium falciparum malaria and mefloquine resistance in western Thailand: a prospective study. Lancet. 2000;356(9226):297-302. 12. Leang R, Barrette A, Bouth DM, Menard D, Abdur R, Duong S, et al. Efficacy of dihydroartemisinin-piperaquine for treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax in Cambodia, 2008 to 2010. Antimicrob Agents Chemother. 2013;57(2):818-26. 13. van der Pluijm RW, Imwong M, Chau NH, Hoa NT, Thuy-Nhien NT, Thanh NV, et al. Determinants of dihydroartemisinin-piperaquine treatment failure in Pla