Birku ETH 96‐7.
Methods | Open randomisation using lottery draw No withdrawals or exclusions loss to follow‐up at 28 d = 3/60 (5%) |
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Participants | 65 Ethiopian adults 23 to 41 years Severe malaria (WHO 1990b), 15 patients had unrousable coma (Glasgow <10) Asexual falciparum parasitaemia Excluded: QNN or SP just before admission; history of liver/kidney disease; pregnant |
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Interventions | ARTpr vs QNNiv:
1. ART 4250 mg (750 mg at 0 h, 500 mg at 12 h, then 500 mg daily on days 2 to 7)
2. QNN 20 mg/kg over 4 h then 10 mg/kg every 8 h, continued per os when able Tepid sponging for fever (> 39 °C sub‐lingual); intravenous fluid for severe dehydration, shock, hypoglycaemia; transfusion for Hb < 5 g/dl and signs of conjestive cardiac failure; dextrose for blood glucose < 2.2 mM/l; nursing care for comatose patients |
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Outcomes | 1. Mortality 2. Coma recovery time 3. PCT 4. PC50 5. FCT 6. Adverse effects | |
Notes | Quality assessment: B, B, A Artemisinin: Mediplantex, Hanoi, Viet Nam |