Danis WAF 93‐4.

Methods	Centralised block randomisation stratified by investigating centre (5 centres), allocation concealed in sealed envelopes, not blinded. Withdrawn = 2/282 (<1%); records lost: 12/180 (4%); excluded after treatment: AM = 7/133 (5%), QNN = 10/135 (7%); loss to follow‐up at d14: 37/268 (14%)
Participants	194 West African children, 3 months to 15 years; 74 adults, 16 to 48 years; febrile One or more criteria for severe malaria, or 3 incidents of vomiting in previous 24h, and one other manifestation of severe malaria (WHO 1990b), cerebral Glasgow score 7 or less, Blantyre 3 or less; asexual falciparum parasitaemia. Excluded: MQ, SP in previous 15 d; H, ART derivative in previous 5 d; QNN in previous 24 h; any intramuscular injection in previous 12 h; other systemic infectious disease; non‐systemic or intracranial disease; renal insufficiency; circulatory arrest; diffuse haemorrhage; pregnancy, breastfeeding; contraindication for intramuscular injection
Interventions	AMim vs QNNiv: 1. AM: < 50 kg, 9.6 mg/kg (1.6 mg/kg at 0 h, 12 h, days 2 to 5; > 50 kg, 480 mg (80 mg at 0 h, 12 h, days 2 to 5) 2. QNN: 20 mg/kg, then 10 mg/kg every 8 h, per os from days 3 to 7 depending on patient clinical state
Outcomes	1. Mortality 2. Time to total parasite clearance (major endpoint) 3. FCT 4. Resolution of coma (Glasgow score 15 in adults with a score of <12, Blantyre score 5 in children with a score of <4) 5. PC50, PC90 6. Safety by clinical, haematological, biochemical & ECG tests
Notes	Quality assessment: A, A, B Paluther Rhone‐Poulenc