Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria, and chloroquine for P.vivax in Budethaung (Rakhine), Thanphyuzayat (Mon State), and Kawthaung (Tanintharyi Division)

Department of Medical Research (Lower Myanmar)0 个研究点目标入组 160 人开始时间: 2010年10月19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 years inclusive and above except females aged 12-17 year old inclusive;
•*mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/microliter asexual forms);
•*presence of axillary equal to or more than 37.5 degrees centigrade or history of fever during the past 24 hours;
•*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 signs of severe falciparum malaria according to the definitions of World Health Organisation (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 Immune Deficiency Virus (HIV)/Acquired Immune Deficiency Syndrom (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); and
•*a positive pregnancy test or breastfeeding;
•*unable to or unwilling to take a pregnancy test or contraceptives.

发起方

Department of Medical Research (Lower Myanmar)