An open-label randomized controlled trial of the efficacy and safety of clindamycin plus quinine compared with artemether-lumefantrine for the treatment of children with uncomplicated falciparum malaria in western Kenya

Kenya Medical Research Institute0 个研究点目标入组 384 人开始时间: 2012年9月25日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•1. Age 6-59 months
•2. Axillary temperature equal to or above 37.5º C or history of fever in the past 48 hours
•3. Body weight above 5.0 kg
•4. Slide-confirmed infection with P. falciparum
•5. Parasitaemia 2,000-200,000 asexual forms per microlitre
•6. Parent/guardian provides informed consent

•1. Presence of general danger signs or other signs of severe malaria and complicated falciparum malaria according to current WHO definitions.
•2. Mixed or mono-infection with another Plasmodium species.
•3. Presence of severe malnutrition, defined as weight-for-age below 3 standard deviations below the mean (NCHS/WHO normalized reference values).
•4. Known hypersensitivity to any of the drugs being tested.
•5. Presence of febrile conditions caused by diseases other than malaria.
•6. Presence of other serious or chronic medical conditions (heart failure, sickle cell disease).
•7. Plan to travel or leave the area within the next 3 months
•8. Inability to swallow oral medication
•9. Residence beyond 10km of the catchment area of the study hospital.

发起方