Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in 3 sentinel sites (LuangPrabang, Khammoune and Attapeu provinces), Lao Peoples’ Democratic Republic

Ministry of Health0 个研究点目标入组 150 人开始时间: 2010年11月3日最近更新: 2020年1月13日

适应症

试验速览

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•age between 6 months and above;
•- mono-infection with P. falciparum detected by microscopy;
•P. falciparum parasitaemia of 250-100,000/u asexual forms;
•- presence of axillary temperature = 37.5 degrees C or history of fever during the past 24 hours;
•- 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 < 110 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;
•- history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and
•- Unmarried women age 12-18 years old
•- a positive pregnancy test or lactating
•- Unable to or unwilling to take contraceptives for pregnancy negative married women of child- bearing age.

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