Conditions: Plasmodium Falciparum Malaria
Keywords: Plasmodium infections Remittent fever Artemether Artemesinins Quinine Malaria Protozoan infections sublingual drug delivery Parasitic disease Antiprotozoan agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 151
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Artemether Sublingual Spray intervention 2: Quinine
Intervention descriptions: intervention 1: Artemether sublingual spray administered at 3 mg/kg (milligrams per kilogram) at specified timepoints intervention 2: Quinine administered intravenously, 20 mg/kg loading dose followed by 10 mg/kg every eight hours

Protocol document: