Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Djibouti-ville, Djibout

Ministry of Health of Djibouti0 个研究点目标入组 95 人开始时间: 2024年7月25日最近更新: 2024年8月5日

适应症

试验速览

The quality control of slide reading and data validation are in progress.

•age between 6 months and above;;
•mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
•parasitaemia of 500-200000 per micrometer asexual forms;
•presence of axillary temperature greater or equal 37.5 degrees centigrade or history of fever during the past 24 h;
•ability to swallow oral medication;
•ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
•informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years;
•informed assent from any minor participant aged from 12 to age of majority years; and

•presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO;
•weight under 5 kg;
•haemoglobin below 8 g per deciliter;
•mixed or mono-infection with another Plasmodium species detected by microscopy;
•presence of severe malnutrition defined as a child aged between 6-60 months who has a mid-upper arm circumference below 115 mm);
•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);
•regular medication, which may interfere with antimalarial pharmacokinetics;
•history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
•a positive pregnancy test or breastfeeding; and

发起方

Ministry of Health of Djibouti