Efficacy and safety of artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria at the Kobéni site (Hodh El Gharbi Province) and Timbédra (Hodh Echargui Province), Mauritania.

Ministry of Health0 个研究点目标入组 120 人开始时间: 2023年8月3日最近更新: 2026年7月20日

适应症

试验速览

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•age between 6 months to and above;
•mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
•parasitaemia of 250-200, 000 per µl asexual forms;
•presence of axillary or tympanic temperature equal to or greater 37.5 centigrade degrees 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 18;
•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 > 12 years and sexually active) and from their parent or guardian if under the age of 18.

•presence of general danger signs in children aged under 12 years or signs of severe malaria according to the definitions of WHO protocol https://cdn.who.int/media/docs/default-source/malaria/template-protocol-for-tet-en.docx?sfvrsn=e9dceb7e_2);
•weight under 5 kg;
•haemoglobin below 8 g per 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, or has symmetrical oedema involving at least the feet or has a mid-upper arm circumference above 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 (defined as age greater 12 years and sexually active).

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