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Evaluation of the efficacy of Artemisinin Combination therapy in Kenya

Surveillance of the invasive Anopheles stephensi malaria vector and pfcoronin and pfk13 gene variants as markers for resistance by P. falciparum to ACTs treatment in ‘resistance high risk’ border counties of Mombasa, Kwale, and Busia; A strategic

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202404710340979
Enrollment
330
Registered
2024-04-30
Start date
2024-05-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Artemether Lumefantrine

Sponsors

Kenya Medical Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • age between 6 Months to 14 years • mono infection with P. falciparum confirmed by positive blood smear (i.e., no mixed infection). • parasitaemia of parasitaemia between 1,000 – 200,000 p/µl • presence of axillary or tympanic temperature = 37.5 °C or fever history during the past 24 h. • ability to swallow oral medication. • ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule. • informed consent from a parent or guardian and an informed assent from any minor participant aged from 12 to 14 years

Exclusion criteria

Exclusion criteria: • presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1) • weight under 5 kg. • haemoglobin 12 years and sexually active)

Design outcomes

Primary

MeasureTime frame
Adequate clinical Parasitological Response

Secondary

MeasureTime frame
1. Highlight the prevalence of Pfk13 antimalarial drug resistance marker. 2. Determine the use of the novel marker, Pfcoronin, as an indication for antimalarial drug resistance

Countries

Kenya

Contacts

Public ContactElijah Songok

Director General Kenya Medical Research Institute

director@kemri.go.ke+2540202722541

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026