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This study compares the malaria treatments Arterolane-piperaquine, Arterolane-piperaquine plus Mefloquine, and Artemether-lumefantrine in Kenyan children. Children aged 2 to under 13 with uncomplicated P. falciparum malaria may take part. The study was conducted in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Male or female aged 2 years to \<13-year-old 2. Uncomplicated falciparum malaria as defined as: * Positive blood smear with asexual forms of P. falciparum (may be mixed with non-falciparum species) * Parasitaemia between 5,000-250,000 parasites/µL * Fever defined as tympanic temperature \>37.5°C or history of fever within last 48 hours 3. Ability to take oral medication 4. Willingness and ability to comply with study protocol for study duration 5. Written informed consent given to participate in the trial Exclusion Criteria: 1. Signs of severe/complicated malaria\* 2. Any clinical reason suggesting that the child's treatment should be given immediately and not delayed during the transfer to Kilifi County Hospital in the opinion of the treating physician. 3. Acute illness other than malaria requiring urgent systemic treatment as assessed by the treating physician 4. Previous splenectomy 5. Treatment with artemisinin or ACT within the previous 7 days 6. Treatment with mefloquine in the 2 months prior to presentation 7. Known hypersensitivity or contraindication to arterolane-piperaquine, DHA-piperaquine, artemisinin, mefloquine (epilepsy, major psychiatric illness) or primaquine 8. QTc interval \>450 milliseconds at point of presentation 9. Known personal or family history of cardiac conduction problems 10. Participation within another clinical trial in the previous 3 months