Efficacy (adequate clinical and parasitological response-ACPR) as well failure (early treatment failure-ETF, late clinical failure-LCF, late parasitological failure-LPF) of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria patients in Teknaf Upazila of Cox’s Bazar district, Lama Upazila of Bandarban district and Kalmanda Upazila of Netrakona district in Bangladesh.

Ministry of Health and Family Welfare0 个研究点目标入组 270 人开始时间: 2012年9月3日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. All patients above 6 months of age except girls between 12-18 years and unmarried women;
•2. Malaria positive P. falciparum mono-infection with parasite density of 1,000-100,000 parasites/micro-litre;
•3. Axillary temperature > 37.5 degree Centigrade or history of fever during the past 24 hours;
•4. Ability to swallow oral medication;
•5. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
•6. Informed consent from the patient or from a parent or guardian in the case of children.

•1. Presence of general danger signs or other signs of severe and complicated falciparum malaria according to current WHO definitions.
•2. Mixed or mono-infection with another Plasmodium species detected by microscopy;
•3. Presence of severe malnutrition (defined as a child who has a mid-upper arm circumference < 110 mm)
•4. Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS);
•5. Regular medication, which may interfere with antimalarial pharmacokinetics;
•6. History of hypersensitivity reactions or contraindications to the medicine being tested;
•7. A positive pregnancy test or breastfeeding;
•8. Unmarried women and girls between 12-18 years;
•9. Unable to or unwilling to take contraceptives (for married women of child-bearing age)

发起方