Efficacy and safety of artesunate-mefloquine for the treatment of uncomplicated Plasmodium falciparum malaria in Binh Phuoc and Dak Nong provinces, Viet Nam, in 2019.

World Health Organization0 个研究点目标入组 84 人开始时间: 2020年12月22日最近更新: 2021年1月5日

适应症

试验速览

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•age between 02 to 60 ages;
•mono-infection with P. falciparum detected by microscopy;
•parasitaemia from 500 to 100,000/µl asexual forms;
•presence of axillary temperature greater than or equal to 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; and
•informed consent from the patient or from a parent or guardian in the case of children.
•informed assent from any minor participant aged from 12 to 18 years; and
•consent for pregnancy testing from female of child-bearing age (defined as age over 12 years and sexually active) and from their parent or guardian if under the age of majority years (18 years old).

•presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO
•weight under 5 kg;
•mixed or mono-infection with another Plasmodium species detected by microscopy;
•presence of severe malnutrition defined as a child aged 6-60 months whose weight-for-high is below –3 z-score, has symmetrical oedema involving at least the feet or 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;
•history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
•a positive pregnancy test or breastfeeding; and
•unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active.
•history of hypersensitivity reactions or contraindications to the medicine(s) being tested; and
•Unmarried female age 12 – 18 years old.

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