The primary objective of the study is to evaluate the effectiveness of 2 intravenous
artesunate dosing regimens (2.4 mg/kg initially and at 12, 24, 48, and 72 hours or 4.0 mg/kg
initially and at 24 and 48 hours) in clearing P. falciparum parasites in children with severe
malaria.
Secondary objectives include:
- To compare the tolerability and safety of the 2 intravenous artesunate dosing regimens.
- To evaluate differences in the pharmacokinetic profile of intravenous artesunate by
patient age and clinical presentation.
Phase:
Phase 2
Details
Lead Sponsor:
Medicines for Malaria Venture
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP) Severe Malaria in African Children Consortium