Efficacy and safety of artesunate+sulfadoxine/ pyrimethamine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Bosaso, Puntland, Somalia

Ministry of Health, Puntland, Somalia0 个研究点目标入组 176 人开始时间: 2015年1月22日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. age between 6 months and 60 years with the exception of 12-17 years old female minors and unmarried females above 18 years and above;
•2. mono-infection with P. falciparum detected by microscopy;
•3. parasitaemia of 500 - 200000 per microliter asexual forms;
•4. presence of axillary temperature greater or equal 37.5 degrees centigrade or history of fever during the past 24 h;
•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;
•7. informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years;
•8. informed assent from any minor participant aged from 12 to age of majority years; and
•9. consent for pregnancy testing from married female of 18 years and above.

•1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
•2. weight under 5 kg;
•3. mixed or mono-infection with another Plasmodium species detected by microscopy;
•4. presence of severe malnutrition (defined as a child aged 6-60 months who has a mid-upper arm circumference < 115 mm;
•5. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
•6. regular medication, which may interfere with antimalarial pharmacokinetics;
•7. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
•8. a positive pregnancy test or breastfeeding of married women aged 18 years and above; and
•9. unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active

发起方

Ministry of Health, Puntland, Somalia