An open label randomised comparison of injectable artesunate and quinine in children with severe falciparum malaria. (360G-Wellcome-082541_Z_07_A)

Severe malaria kills over one million African children each year. Parenteral quinine is the current treatment for in Africa, but in Asia artesunate was shown (SEAQUAMAT trial) to reduce the mortality of severe malaria by 35% compared with quinine and is now recommended by WHO. A meta-analysis of studies comparing artemether (a compound similar, but less well absorbed than artesunate) with quinine indicated that results in Asian adults differed from those in African children, so extrapolation from Asia to Africa may not be warranted. Yet pre-rereferral treatment with rectal artesunate in African children with severe malaria recently reduced mortality by 25%. The objective and design of this study is very similar to the SEAQUAMAT trial; to determine in a definitive randomised trial whether parenteral artesunate reduces the mortality of severe malaria in African children. The trial has started in Mozambique, Kenya, The Gambia, and Ghana, but initial recruitment has been insufficient to meet the target (5,300 patients) required to detect a 25% reduction in overall mortality from 8% to 6%. We propose to more than double the recruitment to the study by adding additional sites. The outcome of this study will determine the future treatment of severe malaria in children.