Efficacy and safety of rectal artesunate in paediatric patients - a randomised controlled study (Ghana and Tanzania)

INTERVENTION: Group A: Artesunate 10 mg/kg, rectal Group B: Quinine 20 mg dihydrochloride salt/kg, intra‐muscular injection (followed by 10 mg/kg at 12 and 24 hours) CONDITION: Malaria ; Infections and Infestations ; Malaria PRIMARY OUTCOME: 28‐day disease‐free survival, defined as patients who survived the 28‐day period of follow‐up with the peripheral blood free of the original genotype of malaria parasites. SECONDARY OUTCOME: The parasitological outcomes and tolerability of a single dose of the rectal artesunate in children aged 3 to 24 months with non per os falciparum malaria. INCLUSION CRITERIA: 1. Aged 3 to 24 months 2. Suspected malaria with no other obvious cause of illness 3. P. falciparum asexual parasitaemia greater than ++ (5 ‐ 10 parasites/High Power Field [HPF]) 4. Unable to eat, suck or drink, or repeatedly vomiting (more than three episodes over past 24 hours); or prostrate (unable to sit or stand if previously able to do so) 5. History of convulsions over the preceding 24 hours or impaired consciousness (Blantyre Coma Score less than five) 6. Parent/guardian informed consent