PhuongVNM 92‐5.
Methods | Randomised, method not specified, open Withdrawn before treatment = 2/111 (2%) No exclusions reported No loss to follow‐up at day 7, 67/98 (68%) at day 28 |
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Participants | 109 Vietnamese children 3 months to 14 years More than two thirds had not had malaria before Asexual Pf One or more criteria for severe malaria: Blantyre coma 3 or less; PCV 15% or less with Pf > 10,000/µl; hyperparasitaemia; jaundice; hypoglycaemia; spontaneous bleeding; shock; convulsions; renal impairment Excluded: severe diarrhoea; PfPv; QNN > 60 mg/kg, ART > 20 mg/kg, AS > 2 mg/kg or any antimalarial for more than 48 h for current episode |
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Interventions | ARTpr + MQ15 vs ASim + MQ15 vs QNNiv + SP: 1. ART 120 mg (40 mg at 0 h, 20 mg at 4 h, 24 h, 48 h and 72h + MQ 750 mg at 96 h) 2. AS 11 mg/kg (3 mg/kg at 0 h, 2 mg/kg at 12 h, 24 h, 48 h and 72 h + MQ 750 mg at 96 h) 3. QNN 20 mg/kg, then 10 mg/kg every 8 h to 7 days + Fansidar single dose on day 7 | |
Outcomes | 1. Mortality 2. Neurological sequelae 3. CRT 4. FCT 5. PCT (50, 90, 100%) 6. period in hospital 7. Complications 8. Adverse events | |
Notes | Quality assessment: A, B, A ART suppositories from Vidipha, Viet Nam; AS from Guilin No.2 Pharmaceutical Factory |