KarbwangTHI92‐4.
Methods | Centralised computer generated randomisation, allocation concealed in sealed envelopes opened in sequence, open‐label, microscopists blinded Withdrawn before treatment: AM = 3/50 (6%), QNN = 2/52 (4%); excluded after treatment <10% |
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Participants | 102 Thai adults 15 to 65 years Severe falciparum malaria (WHO 1990b) Excluded: pregnancy; antimalarials in previous 24h; concurrent diseases |
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Interventions | AMim vs QNNiv:
1. AM:160 mg on day 1, 80 mg on days 2 to 7
2. QNN: 20 mg/kg on day 1, 10 mg/kg every 8 h to day 7 QNN loading dose not given if history of previous antimalarial treatment Renal failure managed by dialysis; antibiotics, anticonvulsants, antiemetics, ulcer medication, sedative, paracetamol, diuretics, vasopressors, packed RBC as required |
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Outcomes | 1. Mortality by day 7 2. FCT 3. PCT (rate graph) 4. Time to recover conciousness 5. Incidence of complications 6. Neurological sequelae 7. Adverse effects | |
Notes | Quality assessment: A, A, A AM: Paluther (80 mg/ml) Rhone Poulenc Rorer, manufactured by Kunming, China; Artemetheri for injection, Kunming, starting from patient #41 |