CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 151 enrolled
Drug / intervention
Artemether Sublingual Spray +1 moredrug
Likely dose
Artemether Sublingual Spray 3 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.

Search/NCT01258049
NCT01258049Phase 3Completed
CompareCT.gov

A Phase III, Randomised, Open Labelled, Active Controlled, Multi Centre, Superiority Trial of ArTiMist™ Versus Intravenous Quinine in Children With Severe or Complicated Falciparum Malaria, or Uncomplicated Falciparum Malaria With Gastrointestinal Complications.

Proto Pharma Ltd·interventional·Posted Dec 10, 2010·Updated Feb 28, 2014

In Brief

A Phase 3 clinical trial evaluating Artemether Sublingual Spray and Quinine for Plasmodium Falciparum Malaria. Completed, enrolled 151 participants across 3 sites in 3 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlasmodium Falciparum Malaria
CountriesBurkina Faso, Ghana, Rwanda
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2010
Enrollment StartDec 1, 2010
Primary CompletionAug 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.6 years ago

Interventions

Artemether Sublingual Spraydrug

Artemether sublingual spray administered at 3 mg/kg (milligrams per kilogram) at specified timepoints

Quininedrug

Quinine administered intravenously, 20 mg/kg loading dose followed by 10 mg/kg every eight hours