An open-label randomized study evaluating the efficacies of artemether-lumefantrine (ART/LUM®) and dihydroartemisinin/piperaquine in the treatment of uncomplicated Plasmodium falciparum malaria in children under five years of age under different epidemiological settings in Kenya

未提供0 个研究点目标入组 466 人开始时间: 2011年9月7日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•1.Presentation to the Health facility with probable clinical malaria.
•2.Presence of fever ¿ 37.50C (axillary)
•3.Aged between 6 and 59 months, inclusive
•4.Weight ¿ 5 kgs
•5.Mono-infection with P.falciparum at an asexual parasite density of 1000 ¿ 200,000 parasites per ¿l in malaria
•6.Not suffering from severe and complicated forms of malaria (according to WHO, 2000 classification)
•7.Able to take drugs under study by the oral route
•8.Parent or guardian gives an informed written consent to participate in study

•1.Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb ¿5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (parasites >200,000 ¿l).
•2.General clinical condition calling for hospitalization
•3.Evidence of concomitant infections/disease at the time of presentation
•4.Past or present history of chronic illnesses or any other underlying illness that would compromise the diagnosis and evaluation of the response to the study drug
•5.History of allergy to artemisinin, lumefantrine or piperaquine
•6.Full treatment with other antimalarial drugs within the past 14 days

发起方

未提供