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

Staedke 2003 UGA (Continued)
2. Artesunate plus amodiaquine
• AS 4 mg/kg once daily for 3 days
• AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2
All doses supervized. Meds crushed and mixed with chocolate to mask the colour and
taste.
Outcomes 1. Risk of treatment failure at day 28, PCR unadjusted
2. Gametocytes during follow up
3. Anaemia during follow up
4. Adverse events
Not included in the review:
1. Risk of treatment failure at day 28, PCR adjusted (only late clinical failures
underwent PCR testing)
2. Fever clearance
3. Parasite clearance
Notes Country: Uganda
Setting: Urban hospital
Transmission: Mesoendemic with peaks in the 2 rainy seasons
Resistance: CQ and SP resistance
Dates: Aug 2002 to July 2003
Funding: NIH and the Fogarty International Centre/NIH
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes ’An off-site investigator generated randomization
codes with a computer for two age
groups using variable blocking’
Allocation concealment? Yes ’Sequentially numbered sealed envelopes
containing the treatment group assignments
were prepared from the randomization
lists’
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
Yes ’All study personnel (excluding study
nurse), including the doctors, were unaware
of the treatment assignments’
Yes Losses to follow up were low in both groups
(3% AS+AQ vs 3.7% AQ+SP)
Free of selective reporting? Yes We were unable to use PCR adjusted data
as PCR was only performed on late clinical
failures, not on late parasitological failures
Free of other bias? Yes No other sources of bias identified
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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