Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in sentinel sites of Comores

Ministry of Health, Solidarity and Propotion of gender0 个研究点目标入组 240 人开始时间: 2010年10月21日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•*age between 6 and 59 months inclusive in Ngazidja and Ndzouani sites and between 6 months and 12 years inclusive in Mwali site;
•*mono-infection with P. falciparum detected by microscopy (parasitaemia of 2000-200,000/microliterl asexual forms) except at Mwali site 1000-200000/microliter;
•*presence of axillary equal to or more than 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; and
•*informed consent from the patient or from a parent or guardian in the case of children.

•*presence signs of severe falciparum malaria according to the definitions of World Health Organization (WHO);
•*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 below 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 Immuno Deficiency Virus /Auto Immune Deficiency Syndrome(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);

发起方

Ministry of Health, Solidarity and Propotion of gender