CompletedPhase 4

Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia

Liberia352 participantsStarted 2022-08-09

Plain-language summary

To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia.

Who can participate

Age range6 Months – 59 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age between 6 to 59 months (5 years)
✓. Weight ≥ 5 kg
✓. Monoinfection with P. falciparum with a parasite density of 2,000 to 200,000 asexual forms per microliter of blood
✓. Axillary temperature ≥37.5˚C or history of fever in the last 24 hours
✓. Hemoglobin ≥ 8.0g/dl
✓. Easy access to the health facility and ability to return to the health facility over the course of the four weeks of follow-up
✓. Informed consent of parent or guardian

Exclusion criteria

✕. Any danger signs or signs of severe malaria (see Appendix I)
✕. Pneumonia or bronchopneumonia
✕. Severe malnutrition (Z-score \< 3)
✕. History of taking antimalarials (or antibiotics with antimalarial activity such as cotrimoxazole, tetracycline or doxycycline) in the last 14 days
✕. Mixed malaria infection
✕. History of hypersensitivity or allergy to the medication

What they're measuring

Number of Participants with Early Treatment Failure (ETF)

Timeframe: Day 1 to day 3 following treatment.

Number of Participants with Late Treatment Failure (LTF)

Timeframe: Day 4 to day 28 following treatment.

Number of Participants with Adequate Clinical and Parasitological Response (APCR)

Timeframe: Day 28 following treatment.

Trial details

NCT IDNCT06300970

SponsorCenters for Disease Control and Prevention

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2023-08-16

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