Assessment of the therapeutic efficacy, in terms of proportion of patients with PCR-corrected adequate clinical and parasitological response of the combination of artesunate plus sulfadoxine-pyrimethamine and that of the fixed combination of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in patients over 6 months of age recruited from Kassala, Kosti, Sinnar, Damazin, and Gadaref, Sudan

Republic of Sudan Federal Ministry of Health0 个研究点目标入组 704 人开始时间: 2013年8月27日最近更新: 2020年1月13日

试验速览

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•Age above six months excluding female minors aged 12-17 years inclusive and unmarried women above 17 years;
•Mono-infection with P. falciparum detected by microscopy;
•Parasitaemia of 1000-100,00 per microlieter asexual forms;
•Presence of axillary temperature equal or greater 37.5 degrees Celsius, or history of fever during the past 24 h;
•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 general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of 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 less than 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, HIV/AIDS);
•Regular medication, which may interfere with antimalarial pharmacokinetics;
•History of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatments; and
•A positive pregnancy test or breastfeeding.

发起方

Republic of Sudan Federal Ministry of Health