Efficacy and safety of artemeter-lumefantrine in the treatment of uncomplicated malaria-causing Plasmodium falciparum infections in Botswana

Ministry of Health0 个研究点目标入组 261 人开始时间: 2009年5月15日最近更新: 2020年1月13日

适应症

试验速览

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•age six months and above;
•mono-infection with Plasmodium falciparum detected by microscopy;
•parasitaemia of 500–200 000 asexual forms /microl blood;
•presence of axillary temperature = 37.5 degre C and/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; and
•informed consent from the patient or 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 World Health Organization;
•mixed or mono-infection with another Plasmodium species detected by microscopy;
•presence of severe malnutrition (defined as a child whose growth standard is below –3 Z score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm);
•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, human immunodeficiency virus/acquired immunodeficiency syndrome);
•regular medication, which may interfere with antimalarial pharmacokinetics;
•history of hypersensitivity reactions or contraindications to any of the drug(s) being tested or used as alternative treatment(s); and
•a positive pregnancy test or breastfeeding.

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