NCT01047436

Efficacy of ArTiMist™ in Children

An Open Label Randomised Comparative Trial to Establish the Efficacy of 3 mg/kg ArTiMist™ When Compared to Intravenous Quinine in Children With Severe or Complicated Falciparum Malaria, or Uncomplicated Falciparum Malaria With Gastrointestinal Complications

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Proto Pharma Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with gastrointestinal complications.

Conditions

• Falciparum Malaria

Interventions

Type	Name	Description
DRUG	Quinine	20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy
DRUG	Artemether	Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2010-01-12
• Last updated: 2011-01-27
• Results posted: 2011-01-14