BACKGROUND: Severe malaria is a major cause of childhood death and often the main reason for paediatric hospital admission in sub-Saharan Africa. Quinine is still the established treatment of choice, although evidence from Asia suggests that artesunate is associated with a lower mortality. We compared parenteral treatment with either artesunate or quinine in African children with severe malaria. METHODS: This open-label, randomised trial was undertaken in 11 centres in nine African countries. Children (<15 years) with severe falciparum malaria were randomly assigned to parenteral artesunate or quinine. Randomisation was in blocks of 20, study numbers corresponding treatment allocations kept inside opaque sealed paper envelopes. The trial open label at each site, and none the investigators trialists, apart from for statistician, had access summaries allocations. primary outcome measure in-hospital mortality, analysed by intention treat. This is registered, number ISRCTN50258054. FINDINGS: 5425 children enrolled; 2712 2713 All patients outcome. 230 (8.5%) died compared 297 (10.9%) quinine (odds ratio [OR] stratified site 0.75, 95% CI 0.63-0.90; relative reduction 22.5%, 8.1-36.9; p =0.0022). Incidence neurological sequelae did not differ significantly between groups, but development coma (65>
Dondorp, A. M., Fanello, C. I., Hendriksen, I. C., Gomes, E., Seni, A., Chhaganlal, K. D., Bojang, K., Olaosebikan, R., Anunobi, N., Maitland, K., Kivaya, E., Agbenyega, T., Nguah, S. B., Evans, J., Gesase, S., Kahabuka, C., Mtove, G., Nadjm, B., Deen, J., Mwanga-Amumpaire, J., Nansumba, M., Karema, C., Umulisa, N., Uwimana, A., Mokuolu, O. A., Adedoyin, O. T., Johnson, W. B., Tshefu, A. K., Onyamboko, M. A., Sakulthaew, T., Ngum, W. P., Silamut, K., Stepniewska, K., Woodrow, C. J., Bethell, D., Wills, B., Oneko, M., Peto, T. E., von Seidlein, L., Day, N. P., White, N. J.