Published on 5 October 2012
Recruitment completed for clinical trial evaluating parenteral artesunate regimen for children with severe malaria
The Severe Malaria in African Children network (SMAC) completed enrolment of patients for the phase III artesunate follow-up study led by Prof. Kremsner (University of Tübingen). A total of 1,046 children with severe malaria are enrolled in this study and the end of follow-up period for the last patient enrolled is expected to be reached by the end of October 2012. The primary objective of the study is to further evaluate simplification of the treatment of severe malaria by administering artesunate in a three-dose regimen intramuscularly rather than intravenously.
The overall goal of this Phase III Comparative, Open-Label, Dose and Regimen Optimisation Follow-up Study is to compare the efficacy, safety and tolerability of three-dose regimens: intravenous (iv) artesunate and intramuscular (im) artesunate simplified dosing regimens (4 mg/kg artesunate at 0, 24 and 48 hours; 12 mg/kg total dose) and the standard iv 5-dose regimen (2.4 mg/kg artesunate at 0, 12, 24, 48 and 72 hours; 12 mg/kg total dose).
If the outcome of this study is positive, further simplification of the treatment of severe malaria by administering artesunate in a three-dose regimen intramuscularly will contribute to reducing costs and improving severe malaria management in resource limited settings. These results will inform future policy and evidence-based changes in the WHO guidelines for malaria treatment.
Earlier SMAC phase II study
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