Surveillance of the invasive Anopheles stephensi malaria vector and pfcoronin and pfk13 gene variants as markers for resistance by P. falciparum to ACTs treatment in ‘resistance high risk’ border counties of Mombasa, Kwale, and Busia; A strategic

Kenya Medical Research Institute0 个研究点目标入组 330 人开始时间: 2024年4月9日最近更新: 2024年5月27日

适应症

试验速览

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•age between 6 Months to 14 years
•mono infection with P. falciparum confirmed by positive blood smear (i.e., no mixed infection).
•parasitaemia of parasitaemia between 1,000 – 200,000 p/µl
•presence of axillary or tympanic temperature = 37.5 °C or fever history 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 a parent or guardian and an informed assent from any minor participant aged from 12 to 14 years

•presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1)
•weight under 5 kg.
•haemoglobin < 5 g/dl
•mixed or mono infection with another Plasmodium species detected by microscopy.
•presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below –3 z-score,
•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 girls of child-bearing age (defined as age > 12 years and sexually active)

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