EFFICACY AND SAFETY OF ARTEMETHER LUMEFANTRINE, PYRONARIDINE ARTESUNATE, ARTESUNATE AMODIAQUINE, AND DIHYDROARTEMISININ PIPERAQUINE FOR THE TREATMENT OF UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA IN CHILDREN IN UGANDA

未提供0 个研究点目标入组 1,350 人开始时间: 2022年12月5日最近更新: 2023年5月29日

适应症

试验速览

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•age 6 months to 10 years;
•mono-infection with P. falciparum confirmed by positive blood smear;
•parasitaemia of 2000 to 200000 asexual forms/µl;
•presence of axillary temperature = 37.5 °C 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;
•informed consent from parent or guardian;
•Haemoglobin > 8.0 g/dl

•presence of general danger signs in children aged under 11 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
•weight under 5 kg;
•mixed or mono-infection with another Plasmodium species detected by microscopy;
•presence of severe malnutrition defined as a very low weight for height (below -3z scores of the median WHO growth standards), by visible severe wasting, or by the presence of nutritional oedema. In a child aged between 6-60 months who has a mid-upper arm circumference < 115 mm;
•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);
•regular medication, which may interfere with antimalarial pharmacokinetics (Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocystis carini pneumonia in children born to HIV positive women);
•history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).

发起方

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