Efficacy and safety of Artemether-Lumefantrine and dihydroartimisininne-pipraquine for the treatment of uncomplicated Plasmodium falciparum malaria in different sentinel site in Sudan

Ministry of Health0 个研究点目标入组 362 人开始时间: 2018年11月5日最近更新: 2021年11月1日

适应症

试验速览

暂无简介。

•1.Age above six months excluding female minors (from 12 years) and unmarried females.
•2.mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
•3.parasitaemia of 1000 to 100000 asexual parasite per microliter blood;
•4.presence of axillary temperature egual or greater than 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 the patient or from a parent or guardian in the case of children aged less than age of majority;
•8.informed assent from any minor participant aged from 12 to below below age of majority (18 years); and
•9.consent for pregnancy testing from married female of child-bearing age

•1.presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO;
•2.unmarried female in the child bearing age
•3.weight under 5 kg;
•4.mixed or mono-infection with another Plasmodium species detected by microscopy;
•5.presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below –3 z-score
•6.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);
•7.regular medication, which may interfere with antimalarial pharmacokinetics;
•8.history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
•9.a positive pregnancy test.
•10.Unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age (defined as age above 12 years and sexually active).

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