Efficacy and safety of two artemisinin based combination therapies (CTAs) for the treatment of uncomplicated Plasmodium falciparum malaria in Burkina Faso

Improving Malaria Care (IMC Project)0 个研究点目标入组 720 人开始时间: 2017年8月3日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Age, 6¿59 months,
•Mono-infection with P. falciparum detected by microscopy;
•Asexual parasite count of 2000¿200 000/¿l
•Axillary temperature ¿ 37.5 °C or history of fever during the previous two weeks;
•Hemoglogin ¿ 8g/dl
•Ability to swallow oral medication;
•Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule;
•Informed consent from a parent or guardian in the case of children

•Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO
•Body weight less than 5 kg;
•Presence of severe malnutrition (defined as a child whose growth standard is below ¿3 z-score);
•Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea withdehydration) 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)
•Known individual or familly history of clinically significant prolonged QTc or subite death
•Previous particpation to malaria vaccine trial

发起方

Improving Malaria Care (IMC Project)