Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Palsmodium falciparum malaria in Lambarene, Gabon

Ministry of Health and Population Gabon0 个研究点目标入组 120 人开始时间: 2016年11月18日最近更新: 2020年3月16日

适应症

试验速览

暂无简介。

•1.age 6 months to 12 years old
•2.mono-infection with P. falciparum detected by microscopy;
•3.parasitaemia of 1000–100,000/microliter asexual forms;
•4.presence of axillary temperature greater than or equal 37.5 degrees 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

•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.Haemoglobin below 8g/dl;
•4.mixed or mono-infection with another Plasmodium species detected by microscopy;
•5.presence of severe malnutrition (defined as a child aged 6-60 months who has symmetrical oedema involving at least the).
•6.presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea 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);

发起方

Ministry of Health and Population Gabon