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Malaria (Plasmodium Falciparum)ETH-ART-RNCT07527182

Artemisinin Partial Resistance in Ethiopian Plasmodium Falciparum: A Multisite Clinical, Molecular and In Vitro Study

A study testing Artemether-Lumefantrine Tab 20-120mg in people with Malaria (Plasmodium Falciparum) and Drug Resistance, run by Didier Menard at 5 sites in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Artemisinin-based combination therapies (ACTs) are the main treatment for falciparum malaria in Africa. Artemisinin partial resistance (ART-R), characterized by delayed parasite clearance after treatment, has been confirmed in four sub-Saharan African countries. Read more about this study

Who is it for?
Ages 6 months and older
What is being tested?
Artemether-Lumefantrine Tab 20-120mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
277 participants
Where
5 sitesEthiopia
Study dates
1 May 2024to 7 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Age ≥ 6 months
  • Microscopically confirmed uncomplicated Plasmodium falciparum monoinfection
  • Axillary temperature ≥ 37.5°C or history of fever in the past 24 hours
  • Ability to take oral medication
  • Written informed consent from patient or parent/guardian
  • Residence in the study area with intention to remain during follow-up

Who cannot join

  • Severe or complicated malaria (WHO criteria)
  • Mixed Plasmodium infection
  • Pregnancy or breastfeeding
  • Known hypersensitivity to artemether-lumefantrine
  • Antimalarial treatment in the 4 weeks prior to enrollment
  • Severe malnutrition
  • Concomitant febrile illness other than malaria requiring systemic treatment

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Ethiopia5 sites

  • Bako Health Center

    Bako

  • Workamba Health Center

    Kechemo

  • Mehoni Health Center

    Mersa, Tigray

  • Metahara Health Center

    Metehara

  • Rama Health Center

    Rama

Other trials in Ethiopia

About this study

Official title: Confirmation of Artemisinin Partial Resistance in Plasmodium Falciparum Using WHO Criteria: A Multisite Clinical, Molecular and Phenotypic Study Across Five Sentinel Sites in Ethiopia, 2024-2025

Artemisinin-based combination therapies (ACTs) are the main treatment for falciparum malaria in Africa. Artemisinin partial resistance (ART-R), characterized by delayed parasite clearance after treatment, has been confirmed in four sub-Saharan African countries. In Ethiopia, molecular surveys have detected the Pfkelch13 R622I mutation associated with ART-R at multiple sites, but no study has yet combined clinical, molecular, and in vitro evidence to confirm ART-R per WHO criteria. This multisite study conducted across five sentinel sites in Ethiopia (2024-2025) assessed day-3 parasite positivity after artemether-lumefantrine treatment, Pfkelch13 genotyping, and ring-stage survival assay on culture-adapted field isolates, to determine whether ART-R is confirmed in Ethiopian Plasmodium falciparum populations.

Read the detailed description

This study integrated three WHO-required lines of evidence to confirm artemisinin partial resistance (ART-R) in Ethiopia: (1) clinical evidence through day-3 parasite positivity assessment after artemether-lumefantrine treatment in therapeutic efficacy studies; (2) molecular evidence through Pfkelch13 propeller domain genotyping; and (3) phenotypic in vitro evidence through ring-stage survival assay (RSA0-3h) on culture-adapted field isolates. Five sentinel sites were selected across malaria-endemic regions of Ethiopia. Blood samples were collected at enrollment (day 0) and day 3. Isolates were cryopreserved and shipped to France (Strasbourg) for RSA.

Being tested
Artemether-Lumefantrine Tab 20-120mg
Keywords
Artemisinin partial resistance, Plasmodium falciparum, Pfkelch13, Ring-stage survival assay, Day-3 positivity, Ethiopia, Artemether-lumefantrine, Antimalarial drug resistance
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 Tab 20-120mgDrug

    Also called Coartem

    Artemether-lumefantrine (Coartem) administered orally twice daily for 3 days at weight-based dosing per Ethiopian national malaria treatment guidelines.

Study groups in NCT07527182
Study groupRoleWhat they receive
Artemether-LumefantrineExperimentalPatients with uncomplicated Plasmodium falciparum malaria received artemether-lumefantrine (AL) twice daily for 3 days per Ethiopian national treatment guidelines, with clinical follow-up on days 0 and 3.
Receives: Drug: Artemether-Lumefantrine Tab 20-120mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Day-3 Parasite Positivity Rate

    Proportion of patients with microscopically detectable Plasmodium falciparum parasitaemia on day 3 (72 ± 2 hours) after initiation of artemether-lumefantrine treatment, assessed by Giemsa-stained thick blood smear examination.

    Measured: Day 3 (72 hours after treatment initiation)

Secondary outcomes (2)

  1. Prevalence of Pfkelch13 R622I Mutation

    Proportion of day-0 samples carrying the validated Pfkelch13 R622I mutation, assessed by targeted amplicon sequencing.

    Measured: Day 0 (enrollment)

  2. Ring-Stage Survival Rate

    In vitro survival rate of culture-adapted field isolates after 6-hour exposure to 700 nM dihydroartemisinin, assessed by ring-stage survival assay (RSA0-3h). Resistance threshold: survival rate >1%.

    Measured: Assessed on culture-adapted isolates collected at Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start1 May 2024
  3. Primary completion30 Oct 2025
  4. Study completion7 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm therapeutic efficacy study. All enrolled patients with uncomplicated Plasmodium falciparum malaria received artemether-lumefantrine (AL) per Ethiopian national treatment guidelines. Clinical, molecular, and in vitro outcomes were assessed to determine whether artemisinin partial resistance meets WHO confirmation criteria.
Masking
None (open label)
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07527182
Sponsor's protocol ID
ETH-ARTR-2024
Acronym
ETH-ART-R
Status last verified
Apr 2026
First submitted
7 Apr 2026
Last updated
14 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) underlying the results reported in the published article will be made available upon reasonable request to the corresponding author, following publication. Data will include anonymized clinical outcome data, Pfkelch13 genotyping results, and ring-stage survival assay results.

Publications

  • Uwimana A, Legrand E, Stokes BH, Ndikumana JM, Warsame M, Umulisa N, Ngamije D, Munyaneza T, Mazarati JB, Munguti K, Campagne P, Criscuolo A, Ariey F, Murindahabi M, Ringwald P, Fidock DA, Mbituyumuremyi A, Menard D. Emergence and clonal expansion of in vitro artemisinin-resistant Plasmodium falciparum kelch13 R561H mutant parasites in Rwanda. Nat Med. 2020 Oct;26(10):1602-1608. doi: 10.1038/s41591-020-1005-2. Epub 2020 Aug 3.

    PubMed 32747827

  • Balikagala B, Fukuda N, Ikeda M, Katuro OT, Tachibana SI, Yamauchi M, Opio W, Emoto S, Anywar DA, Kimura E, Palacpac NMQ, Odongo-Aginya EI, Ogwang M, Horii T, Mita T. Evidence of Artemisinin-Resistant Malaria in Africa. N Engl J Med. 2021 Sep 23;385(13):1163-1171. doi: 10.1056/NEJMoa2101746.

    PubMed 34551228

  • Mihreteab S, Platon L, Berhane A, Stokes BH, Warsame M, Campagne P, Criscuolo A, Ma L, Petiot N, Doderer-Lang C, Legrand E, Ward KE, Zehaie Kassahun A, Ringwald P, Fidock DA, Menard D. Increasing Prevalence of Artemisinin-Resistant HRP2-Negative Malaria in Eritrea. N Engl J Med. 2023 Sep 28;389(13):1191-1202. doi: 10.1056/NEJMoa2210956.

    PubMed 37754284

  • Fola AA, Feleke SM, Mohammed H, Brhane BG, Hennelly CM, Assefa A, Crudal RM, Reichert E, Juliano JJ, Cunningham J, Mamo H, Solomon H, Tasew G, Petros B, Parr JB, Bailey JA. Plasmodium falciparum resistant to artemisinin and diagnostics have emerged in Ethiopia. Nat Microbiol. 2023 Oct;8(10):1911-1919. doi: 10.1038/s41564-023-01461-4. Epub 2023 Aug 28.

    PubMed 37640962

  • Chala B, Platon L, Tibiri YNG, Strubel PE, Thiebaut L, Wade A, Caspar E, Muller A, Bastien M, Nigussie H, Zhang Q, Cao J, Lu F, Piola P, Mamo H, Golassa L, Menard D. Clinical, molecular, and in vitro evidence of artemisinin partial resistance in Ethiopian Plasmodium falciparum: a prospective, multisite, surveillance study. Lancet Infect Dis. 2026 Aug 4:S1473-3099(26)00301-4. doi: 10.1016/S1473-3099(26)00301-4. Online ahead of print.

    PubMed 42551453

Questions about this trial

What is this clinical trial studying?

A study testing Artemether-Lumefantrine Tab 20-120mg in people with Malaria (Plasmodium Falciparum) and Drug Resistance, run by Didier Menard at 5 sites in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Day-3 Parasite Positivity Rate (time frame: Day 3 (72 hours after treatment initiation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07527182, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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