Taylor MAL 92‐4.
Methods | Centralised computer generated randomisation, allocation concealed in sealed envelopes opened in sequence, open‐label, microscopists blinded Withdrawn: AM = 12/95 (13%), QNN = 7/88 (8%) No loss to follow‐up reported |
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Participants | 183 Malawian children with cerebral malaria, unrousable coma (Blantyre score 2 or less) and asexual falciparum parasitaemia Excluded: additional diagnosis; QNN or AM in previous week |
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Interventions | AMim vs QNNiv:
1. AM 3.2 mg/kg, then 1.6 mg/kg daily
2. QNN 20 mg/kg then 10 mg/kg every 8 h (minimum 3 intravenous doses, per os when able to drink) Fansidar (500 mg S, 25 mg P) given at parasite clearance and full recovery |
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Outcomes | 1. Mortality (survival the major criterion for efficacy) 2. Neurological sequelae at 96h 3. FCT 4. PCT (50, 90, 100%) 5. Time to recover full consciousness (Blantyre score 5, or 4 in patients with compromised vision due to malaria) 6. Time to sit, stand, walk, drink, eat 7. Recrudescence at 7 d, 14 d, 21 d and 28 d | |
Notes | Quality assessment: A, A, A Artemetheri for injection 80 mg/ml, Kunming Pharmaceuticals Paluther 8% solution Rhone‐Poulenc, manufactured by Kunming Pharmaceuticals |