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Artemisinin Partial Resistance in Ethiopian Plasmodium Falciparum: A Multisite Clinical, Molecular and In Vitro Study
Sponsor: Didier Menard
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. 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.
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
Key Details
Gender
All
Age Range
6 Months - Any
Study Type
INTERVENTIONAL
Enrollment
277
Start Date
2024-05-01
Completion Date
2026-04-07
Last Updated
2026-04-14
Healthy Volunteers
No
Interventions
Artemether-Lumefantrine Tab 20-120mg
Artemether-lumefantrine (Coartem) administered orally twice daily for 3 days at weight-based dosing per Ethiopian national malaria treatment guidelines.
Locations (5)
Mehoni Health Center
Mersa, Tigray, Ethiopia
Bako Health Center
Bako, Ethiopia
Workamba Health Center
Kechemo, Ethiopia
Metahara Health Center
Metehara, Ethiopia
Rama Health Center
Rama, Ethiopia