drugset / Trial / NCT00522132
Phase II Artesunate Study in Severe Malaria
Phase 2
Completed
200 enrolled
Medicines for Malaria Venture
European and Developing Countries Clinical Trials Partnership (EDCTP) · collabSevere Malaria in African Children Consortium · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2007-09
- Primary completion
- 2008-06
- Completion
- 2008-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artesunate | Small molecule | 2.4 mg/kg | Intravenous |
| Subject | Artesunate | Small molecule | 4 mg/kg | Intravenous |