i.v. Artesunate |
IVAS – intravenous artesunate in children with severe malaria
Children in sub-Saharan Africa typically have not developed adequate immunity against malaria. Consequently, there is a high prevalence of severe malaria cases in this vulnerable patient group with complications such as neurological disorders, organ failure and even death if not treated. To date, most patients with severe malaria are treated intravenously with quinine, which is known to have significant adverse effects and a delicate application procedure. Artesunate is an active, water-soluble derivative of artemisinin, which has been part of traditional Chinese herbal medicine for centuries and was first isolated in 1972. Intravenous (iv) artesunate is now recommended by the World Health Organization (WHO) for the treatment of severe malaria in adults in low malaria transmission areas. However, there is little information on its efficacy in children in high-transmission regions, such as Africa.
Under the direction of the Eberhard Karls University Tübingen, a multicountry Phase II clinical trial with 200 children was initiated to simplify the dosing regimen of iv artesunate, to evaluate its pharmacokinetic profile and to gain experience for its use in African paediatric patients. The trial was funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and Medicines for Malaria Venture (MMV). PMU was approached by MMV to coordinate and monitor the trial in Gabon (Albert Schweitzer Hospital, Lambaréné; Université de Médecine et Science de la Santé, Libreville) and in Malawi (Queen Elizabeth Central Hospital, Blantyre).