Win MYA 89‐91.
Methods | Alternate allocation (allocation to AS treatment was stopped early due to concerns about sterility of the ampuoles; referred patients already on intravenous QNN were kept in the QNN treatment group but later excluded from analysis), microscopists blinded Excluded: 36/180 (20%) Evaluated: AM = 50, AS = 27, QNN = 67 No loss to follow‐up |
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Participants | 144 Burmese male adults 17 to 50 years Unrousable coma (Glasgow scale 3‐9) without other severe complications Falciparum parasitaemia Excluded: other causes of coma; parenteral antimalarial in previous 48h; other complications of malaria; concomitant chronic illness |
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Interventions | AMim + MQ20 vs ASiv + MQ20 vs QNNiv + Tc: 1. AM 600 mg (200 mg, then 100 mg at 12 h, 24 h, 36 h and 48 h) + MQ 1000 mg at 48 h (sequential, single dose) 2. AS 240 mg (120 mg, then 60 mg at 12 h, 24 h and 48 h) + MQ 1000 mg (as before) 3. QNN 600 mg every 8 h for up to 10 days + Tc (250 mg at 48 h then every 6 h for 7 days) | |
Outcomes | 1. Mortality 2. FCT 3. PCT 4. Time to regain conciouness 5. Incidence of complications 6. Recrudescence 7. Side effects | |
Notes | Quality assessment: C, B, B AM (100 mg/amp) from State Pharmaceutical Factory, Yunan; AS (60 mg/ml) from Guilin Pharmaceutical Factory No.2 |
Study code: Name of investigator, COUNTRY CODE, year the study was done (if the year the study was done is not known, the publication date is given in brackets).
ETH: Ethiopia; GAM: Gambia; KEN: Kenya; MAL: Malawi; MYA: Myanmar; NIG: Nigeria; PNG: Papua New Guinea; THI: Thailand; VNM: Viet Nam; WAF: West Africa; Pf: Plasmodium falciparum; Pv: Plasmodium vivax; PfPv: mixed falciparum & vivax infection; ART: artemisinin; AM: artemether; AS: artesunate; QNN: quinine; CLQ: chloroquine; MQ: mefloquine; H: halofantrine; S: sulfadoxine; P: pyrimethamine; Tc: tetracycline; (S): sequential MQ; (C): concomitant MQ; FCT: fever clearance time; PCT: parasite clearance time; PC50/90: time to 50%/90% parasite clearance; CRT: coma recovery time; TESS: treatment emergent signs and symptoms; RBC: red blood cells.
Risk of bias (methodological quality) assessment: used the Cochrane Infectious Diseases Group standard guidelines in terms of allocation concealment, generation of allocation sequence, and inclusion of all randomised participants.