NCT01258049

Superiority of ArTiMist Versus Quinine in Children With Severe Malaria

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Proto Pharma Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed description

Malaria causes significant morbidity and mortality in children in developing countries, despite the availability of highly effective antimalarial therapy. One of the key contributing factors is the delay in the initiation of treatment. ArTiMist is a sublingual formulation of the established antimalarial treatment, artemether. In previous studies good bioavailability has been demonstrated. In an exploratory study (ART003) ArTiMist demonstrated a non statistically significant improvement of 26% (when compared to intravenous quinine) in the numbers of patients experiencing a parasite reduction of \>= 90% within 24 hours of the initiation of treatment. This Phase 3 study is being conducted to establish whether treatment with ArTiMist in children with severe falciparum malaria or uncomplicated falciparum malaria with gastrointestinal complications is at least 20% superior in providing parasitological success (defined as \>= 90% reduction in parasite count at 24 hours after start of treatment) when compared to intravenous quinine.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
DRUG	Artemether Sublingual Spray	Artemether sublingual spray administered at 3 mg/kg (milligrams per kilogram) at specified timepoints
DRUG	Quinine	Quinine administered intravenously, 20 mg/kg loading dose followed by 10 mg/kg every eight hours

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2010-12-10
• Last updated: 2014-02-28
• Results posted: 2014-02-28

Locations

3 sites across 3 countries: Burkina Faso, Ghana, Rwanda