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NCT07527182: ETH-ART-R

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

Completed NA Last updated 14 April 2026
What this trial tests

NA trial testing Artemether-Lumefantrine Tab 20-120mg in Malaria (Plasmodium Falciparum) in 277 participants. Completed in 7 April 2026.

Timeline
1 May 2024
Primary endpoint
30 October 2025
7 April 2026

Quick facts

Lead sponsorDidier Menard
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment277
Start date1 May 2024
Primary completion30 October 2025
Estimated completion7 April 2026
Sites5 locations across Ethiopia

Drugs / interventions tested

Conditions studied

Sponsor

Didier Menard

Who can join

6 Months and older, any sex, with Malaria (Plasmodium Falciparum) or Drug Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing