drugset / Trial / NCT01258049

Superiority of ArTiMist Versus Quinine in Children With Severe Malaria

NCT01258049

Phase 3 Completed 151 enrolled Proto Pharma Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by \>= 90% within 24 hours after the start of treatment in children with severe malaria, or uncomplicated malaria with gastrointestinal complications

Timeline

Start
2010-12
Primary completion
2012-08
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Artemether Small molecule 3 mg/kg Other
Comparator Quinine Small molecule 10 mg/kg Intravenous