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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy
Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy
Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose
Time frame: 24 hours after first dose
Time for Parasite Count to Fall by 90% PCT(90)
The time taken for the parasite count to fall 90% from baseline
Time frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
Time for Parasite Count to Fall by 50% PCT(50)
The time taken for the parasite count to fall 50% from baseline
Time frame: 3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
Parasite Clearance Time
Time in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained
Time frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose
Reduction in parasitaemia from baseline at 24 h after the first dose of study medication
Time frame: 24 hours after first dose
Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose
Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication
Time frame: 12 h (hours) after first dose
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