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NCT Number: NCT07527182

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

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.

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Key information

Conditions

Malaria (Plasmodium Falciparum) Artemisinin-resistant Drug Resistance Ethiopia Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mehoni Health Center, Mersa, Tigray, Ethiopia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Artemether-Lumefantrine Tab 20-120mg

Drug

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

Other names: Coartem

Primary outcomes

  1. Day-3 Parasite Positivity Rate

    Time frame: Day 3 (72 hours after treatment initiation)

    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.

Secondary outcomes

  1. Prevalence of Pfkelch13 R622I Mutation

    Time frame: Day 0 (enrollment)

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

  2. Ring-Stage Survival Rate

    Time frame: Assessed on culture-adapted isolates collected at Day 0

    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%.

Sponsors and collaborators

Lead sponsor

Didier Menard

Other

Registry information

Official study 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

Acronym: ETH-ART-R

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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