Efficacy and safety of Artemether - Lumefantrine for the treatment of children with uncomplicated Plasmodium falciparum malaria in in sentinel sites in Mozambique.

Ministry of Health0 个研究点目标入组 352 人开始时间: 2016年12月6日最近更新: 2020年1月13日

适应症

试验速览

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•1. age from 6 to 59 months;
•2. mono-infection with P. falciparum detected by microscopy;
•3. parasitaemia of 2000 – 200000 asesual/microliter asexual forms;
•4. presence of axillary temperature greater than or equal to 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 parent or guardian

•1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the latest definitions of WHO;
•2. weight under 5 kg;
•3. mixed or mono-infection with another Plasmodium species detected by microscopy;
•4. presence of severe malnutrition defined as a child aged 6-60 months who has a mid-upper arm circumference < 115 mm);
•5. 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);
•6. regular medication, which may interfere with antimalarial pharmacokinetics, (see appendix 2 for detailed list of prohibited medication during the study
•7. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);

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