Artemisinin-based combination therapy for ... - The Cochrane Library

Karunajeewa 2007 PNG (Continued)
Risk of bias
Funding: WHO Western Pacific Region, Rotary against Malaria in Papua New Guinea,
National Health and Medical Research Council of Australia
Item Authors’ judgement Description
Adequate sequence generation? Yes ’Computer-generated randomised assignment
with blocks of 24 for each site’
Allocation concealment? No Not described
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
No An open label trial. Microscopists were unaware
of treatment assignments.
Yes Moderate losses to follow up in all groups
(11.5% AS+SP vs 13.0% DHA-P vs 14.2%
AL6)
Free of selective reporting? Yes All WHO outcomes reported. Day 42
outcomes may underestimate failure with
DHA-P due to its long half-life.
Free of other bias? Yes No other sources of bias identified
Kayentao 2006 MLI
Methods Trial design: An open label 3-arm randomized controlled trial
Follow up: Assessment and malaria film on days 0, 1, 2, 7, 14, and 28. Haemoglobin on
days 0, 14, 28 or day of failure.
Adverse event monitoring: None described
Participants Number: 397 randomized
Inclusion criteria: Age 6 to 59 months, axillary temp > 37.5 ºC, P. falciparum monoinfection
of 2000 to 200,000/µl, informed consent
Exclusion criteria: Danger signs, evidence of another febrile illness, haemoglobin < 5
g/dl
Interventions 1. Artesunate plus amodiaquine, loose combination
• AS 4 mg/kg once daily for 3 days
• AQ 10 mg/kg once daily for 3 days
2. Artesunate plus sulfadoxine-pyrimethamine, loose combination
• AS 4 mg/kg once daily for 3 days
• SP 25/1.25 mg/kg once on the first day
3. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination
• AQ 10 mg/kg once daily for 3 days
• SP 25/1.25 mg/kg once on the first day
All doses supervized
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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