Extrait

Background and study aims. This was the largest ever study in children hospitalized with severe malaria. It sought to determine whether a drug called artesunate was a better treatment than the usual drug quinine. Artesunate had been shown already to be superior in patients (mainly adults) studied in South-East Asia, but uncertainty remained over whether it was better in African children, who bear most of the burden of severe malaria in the world. Who can participate? The study was conducted in 11 centers located in 9 countries across Africa during the study period. All children hospitalized could be enrolled provided the doctor suspected severe malaria, their blood test showed malaria, they were over 18 months of age, and their parent or carer agreed. What does the study involve? The children were randomly allocated to receive one drug or the other by injection or by a drip. The medical staff were all aware of which treatment was given. The primary outcome of the study was whether or not the child survived to leave hospital. We also checked carefully for complications of the disease or the drug, particularly residual brain damage from cerebral malaria. What are the possible benefits and risks of participating? Quinine was the established time-honoured treatment. There were no risks to participating in the study and most children who were eligible were enrolled. Where is the study run from? The study was coordinated by the Mahidol Oxford Research Unit in Bangkok, Thailand When is the study starting and how long is it expected to run for? The study ran between Oct 3, 2005, and July 14, 2010 Who is funding the study? The Wellcome Trust Who is the main contact? Prof NJ White [email protected]

Critère d'inclusion

• Malaria

Liens

• ictrp
• isrctn