Safety and efficacy of artesunate-amodiaquine in four sentinel sites in Burundi for the treatment of uncomplicated malaria

Ministere de la Sante Publique0 个研究点目标入组 352 人开始时间: 2018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 between 6 and 120 months (6 months and 10 years).
•Mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection).
•Parasitemia of 1000 - 200.000 parasites/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 the patient or from a parent or guardian in the case of children aged less than age of majority.

•Pesence of general danger signs in children aged under 12 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 aged between 6-60 months whose weight-for-high is below –3 z-score, or 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).

发起方

Ministere de la Sante Publique