Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated falciparum malaria in children in Bangui and Boali in Central African Republic

Ministry of Health0 个研究点目标入组 176 人开始时间: 2016年10月17日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. age between 6 month and 12 years;
•2. mono-infection with P. falciparum detected by microscopy;
•3. parasitaemia of 1000 - 200000/mocroliter asexual forms;
•4. presence of axillary temperature greater than or equal 37.5 degrees cntigrade 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 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 less than 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 a mid-upper arm circumference < 115 mm);
•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);

发起方