Efficacy and safety of Artesunate+Amodiaquine and Artemether+Lumefatrine for the treatment of uncomplicated Plasmodium falciparum in children malaria in Saclepea-Mahn Comprehensive Health Center (Saclepea-Mahn District, Nimba County), Rennie Hospital (Kakata District, Margibi County) and Sinje Health Center (Garwula District, Cape Mount County and Bensonville Hospital-Montserrado County) in Liberia

Ministry of Health of Liberia0 个研究点目标入组 528 人开始时间: 2017年7月21日最近更新: 2019年11月11日

适应症

试验速览

暂无简介。

•1.age 6-59 months;
•2.mono-infection with P. falciparum detected by microscopy;
•3.parasitaemia of 2000–200000/µl asexual forms;
•4.presence of axillary or tympanic temperature greater or equal to 37.5 degree centigrade or history of fever during the past 24 h
•5.ability to swallow oral medication;
•6.ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
•7.informed consent from a parent or guardian of children aged 6-59 months;
•8.Patients living within 5 km radius of the health facility

•1.Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
•2.Weight under 5 kg;
•3.Mixed or mono-infection with another Plasmodium species detected by microscopy;
•4.Presence of severe malnutrition defined as a child aged 6-59 months whose mid-upper arm circumference less than 115 mm);
•5.Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
•6.Regular medication, which may interfere with antimalarial pharmacokinetics;
•7.History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).

发起方

Ministry of Health of Liberia