An open label clinical trial of the pharmacokinetics of artemether-lumefantrine in pregnant and non-pregnant women with uncomplicated plasmodium falciparum malaria in Kenya

Kenya Medical Research Institute0 个研究点目标入组 75 人开始时间: 2012年11月6日最近更新: 2023年5月29日

适应症

试验速览

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•1.Pregnancy in the second or third trimester or non-pregnant females aged 18 to 40 years
•2.Able to provide informed consent
•3.Presence of fever (Temp ¿ 37.5°C) or a history of fever in the previous 2 days
•4.Presence of asexual P. falciparum monoinfection or mixed infection with P. falciparum as the predominant infection
•5.Initial parasite density of between 1000 and 200,000 asexual parasites / µl of blood
•6.Not suffering from severe and complicated forms of malaria
•7.Haemoglobin ¿ 8g/dl
•8.Able to take drugs under study by the oral route

•1.Severe and/or complicated malaria including severe anaemia (Hb <8 g/dl) and hyper-parasitaemia (>200,000 ¿l)
•2.Patients treated with mefloquine, halofantrine within the 7 days before D0 (Day 0) or with quinine salts and artemisinin derivatives within 3 days before Day 0, or artemether-lumefantrine 30 days before Day 0.
•3.Patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria
•4.Patients with vomiting and/or diarrhoea
•5.Patients with known history of heart disease or arrhythmia
•6.Patients taking concomitant medication that may interfere with study endpoints (see
•7.History of allergy to artemether/lumefantrine or quinine

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