Therapeutic Efficacy Testing of artemether-lumefantrine for the treatment of uncomplicated plasmodium falciparum infection in mainland Tanzania

Ministry of Health of Tanzania0 个研究点目标入组 352 人开始时间: 2012年10月12日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Patients aged 6- months-10 years.
•2. mono-infection with P. falciparum detected by microscopy;
•3. parasitaemia of greater than or equal to 250/microlitre asexual forms;
•4. presence of axillary temperature greater than or equal to 37.5 degrees celsius or history of fever during the past 24 hours
•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; and
•7. Informed consent from the parent or guardian of children.

•1. presence of general danger signs in children aged 6 months-10 years or signs of severe falciparum malaria according to the definitions of WHO;
•2. mixed or mono-infection with another Plasmodium species detected by microscopy;
•3. 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 of less than 110 mm);
•4. 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, HIV/AIDS);
•5. regular medication, which may interfere with antimalarial pharmacokinetics;
•6. 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 of Tanzania