Therapeutic efficacy of Artemether-Lumefantrine for the treatment of uncomplicated Plasmodium falciparum

Centers for Disease Control and Prevention0 个研究点目标入组 528 人开始时间: 2023年9月19日最近更新: 2024年3月4日

适应症

试验速览

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•1. Able to give informed consent, assent and/or parental/guardian permission
•2. Age = 6 months
•3. Weight = 5.0 kg
•4. Hemoglobin = 7 g/dl
•5. Axillary temperature = 37.5º C or history of fever during the previous 24 hours
•6. Ability to swallow oral medication
•7. Slide-confirmed P. falciparum mono-infection with parasite density = 500 parasites per µL.

•1.General danger signs or symptoms of severe malaria
•2.Mixed Plasmodium infection
•3.Anemia defined as hemoglobin < 7 g/dl
•4.Presence of febrile conditions caused by diseases other than malaria
•5.Serious or chronic medical condition
•6.Pregnant or breastfeeding
•7.Refusal to take pregnancy test for women of childbearing age ( 12–49 years)
•8.History of hypersensitivity to study or rescue medication in this study
•9.Taking regular medication which may interfere with antimalarial pharmacokinetics or efficacy
•10.Children weighing less than 5 kilograms
•11.Severe malnutrition in children aged between 6-59 months as defined by the presence of symmetrical edema involving at least the feet or a mid-upper arm circumference < 115 mm

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