ISRCTN69189899已完成不适用

Treatment of uncomplicated childhood malaria by artemether-lumefantrine (Coartem®) efficacy, effectiveness, safety and genotyping in Tanzania

ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)0 个研究点目标入组 360 人开始时间: 2007年5月3日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Males or females less than five years of age with body weight greater than 5 kg
•2. Suffering from acute uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density of 2,000 to 200,000 parasites/µl
•3. Presenting with fever (axillary temperature equal to 37.5°C) or having a history of fever in the preceding 24 hours
•4. Able to ingest tablets orally (either suspended in water or un-crushed with food)

•1. Present with any of the danger signs of severe malaria
•2. Signs/symptoms indicating severe/complicated malaria according to World Health Organization (WHO) criteria (WHO definition)
•3. Serious gastrointestinal disease, severe malnutrition (Weight-for-Height [W/H] less than 70%) or severe anaemia (haemoglobin less than 5 g/dl)
•4. Known hypersensitivity to artemether-lumefantrine
•5. Have been treated with any other drugs within eight weeks prior to screening or intend to use other drugs or biologics during the study

发起方

ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)