Efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Yemen

Ministry of Public Health and Population0 个研究点目标入组 522 人开始时间: 2010年8月24日最近更新: 2020年1月13日

适应症

试验速览

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•1.age 6 months and above;
•2.mono-infection with Plasmodium falciparum (P.falciparum) detected by microscopy;
•3.parasitaemia of 500-200000/microliter asexual forms;
•4.presence of axillary temperature less than or equal to 37.5 degrees centigrade;
•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 patient or from a parent or guardian in the case of children.

•1.presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of World Health Organization (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 <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, Human immunodeficiency virus/Acquired immune deficiency syndrome or acquired immunodeficiency syndrome (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);
•7.unmarried women of child-bearing age;
•8.a positive pregnancy test or breastfeeding;
•9.unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age.

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