At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 31 enrolled
Drug / intervention
Quinine +1 moredrug
Likely dose
Quinine 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Quinine and Artemether for Falciparum Malaria. Completed, enrolled 31 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFalciparum Malaria
Countries--
CollaboratorsXidea Solutions Limited
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
Primary CompletionJan 2010
First PostedJan 2010
TodayJul 2026
First PostedJan 12, 2010
Enrollment StartDec 1, 2009
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.5 years ago
Interventions
Quininedrug
20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy
Artemetherdrug
Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy