Safety and efficacy, in terms of adequate clinical and parasitological response, of artemether lumefantrine for the treatment of children with uncomplicated P. falciparum malaria in Comoros Islands.

Ministere de la Sante, de la Solidarite et de la Promotion du Genre0 个研究点目标入组 560 人开始时间: 2013年5月24日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Age between 6 months to 11 years (inclusive);
•Monoinfection with P falciparum, microscopically confirmed
•Parasitaemia between 500-200,000 per microliter (asexual forms)
•Axillary temperature equal or greater than 37.5 degrees C;
•Able to swallow oral medication;
•Capable and willing to fulfill protocol requirements, including the schedule of assessments for the duration of the study;
•Provide written informed consent (parent or guardian)

•Presence of general danger and signs in children under 5 years or signs of severe falciparum malaria;
•Mixed or mono-infection with another Plasmodium species detected by microscopy;
•History of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatments(s);
•Severe malnutrition (per WHO definition);
•Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea);
•Regular medication, which may interfere with antimalarial pharmacokinetics

发起方

Ministere de la Sante, de la Solidarite et de la Promotion du Genre