Therapeutic efficacy study of a fixed combination of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children and adults using the sentinel surveillance system in Zimbabwe.

Ministry of Health and Child Welfare0 个研究点目标入组 724 人开始时间: 2013年5月29日最近更新: 2020年1月13日

试验速览

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•Age 6 months and above;
•Mono-infection with P. falciparum detected by microscopy;
•Parasitaemia between 1000 to 100,000 per microliter asexual forms;
•Axillary temperature equal or greater than 37.5 degrees C or history of fever within the past 24 hours;
•Ability to swallow oral medication;
•Ability and willingness to comply with the study protocol for the duration of the study including the study visit schedule;
•Informed consent from the patient or parent
•Resident within 5 km radius from study site

•Presence of general danger signs in children under 5 years or signs of severe malaria
•Mixed or mono-infection with another Plasmodium species detected by microscopy;
•Presence of severe malnutrition (according to WHO definitions);
•Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases;
•Regular medication which may interfere with antimalarial pharmacokinetics;
•History of hypersensitivity reaction or contraindications to any of the medicines being tested or used as alternative treatment;
•Positive pregnancy test or breastfeeding (for women of child-bearing age);
•Unable or unwilling to take a preganancy test or contraceptives;
•Resident outside 5 km radius from study site

发起方