A multicentre phase III non-inferiority trial to evaluate safety, tolerability and efficacy of artemether+lumefantrine bi-therapy for the treatment of uncomplicated malaria in African children aged 6 to 59 months

Kwame Nkrumah University of Science and Technology0 个研究点目标入组 1,664 人开始时间: 2021年11月24日最近更新: 2021年11月29日

研究概览

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•1. Children between the age of 6 to 59 months
•2. Body weight =5.0kg
•3. Fever (=37.5°C axillary or 38.0°C oral, rectal or tympanic body temperature) or history of fever in the preceding 24 hours
•4. Uncomplicated P. falciparum mono-infection with equal or more than 1,000 and less than 200,000 asexual P. falciparum parasites per microliter of blood.
•5. Signed written informed consent from the child’s legal representative
•6. Ability to comply with study procedures and follow-up schedules
•7. Willing to stay in study area during the period of follow-up
•8. Ability to take oral medication

•1. Presence of severe malaria following WHO definition
•2. Reported intake of any antimalarial drug within the previous 28 days
•3. Intake of drugs with antimalarial activity or contraindicated drugs within the previous 28 days
•4. Administration of strong inducers or inhibitors of CYP3A4 such as rifampin, carbamazepine, phenytoin, millepertuis/St. John’s wort/
•hypericum perforatum, grapefruit within the previous 28 days
•5. Known history or evidence of clinically significant medical disorders as determined by the investigator
•6. Severe malnutrition assessed by middle upper arm circumference (< 115 mm) according to WHO standard
•7. Screening hemoglobin level <7 g/dL
•8. Known hypersensitivity or contraindications to any AL and/or AP components
•9. Known QT prolongation
•10. Previous participation in a malaria vaccine study
•11. Participation in the ASAAP study during the previous 42 days
•12. Participation in other interventional studies within the previous 28 days
•13. Patients that the investigator considers would be at particular risk if participating in the study

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