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

Kamya 2006 UGA (Continued)
Risk of bias
Dates: Mar 2006 to July 2006
Funding: US Centres for Disease Control, Malaria Consortium Drugman, DFID, DHA-
P supplied by HolleyPharm
Item Authors’ judgement Description
Adequate sequence generation? Yes ’A randomisation list was computer generated
by an off-site investigator’
Allocation concealment? Yes ’Sequentially numbered, sealed envelopes
containing the treatment group assignments
were prepared from the randomisation
list’
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
Yes ’Study physicians and laboratory personnel
involved in assessing outcomes were
blinded to treatment assignments’
Yes Low losses to follow up in both groups
(0.9% AL6 vs 0.9% DHA-P). A large number
of participants were excluded after randomization
for failing to meet the entry criteria.
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
Karema 2004 RWA
Methods Trial design: A 3-arm open label randomized controlled trial
Follow up: History, clinical signs and symptoms, and malaria film on days 0, 1, 2, 3, 7,
14, 21, and 28 and any other day they felt unwell. PCV measured at days 0 and 14.
Adverse event monitoring: An adverse event defined as any unfavourable and unintended
sign associated temporally with the use of the drug administered. Differential WBC
count (and liver function tests at 1 site only) assessed at days 0 and 14.
Participants Number: 762 randomized
Inclusion criteria: Age 12 to 59 months, weight > 10 kg, axillary temp > 37.5 ºC or
history of fever in the preceding 24 hrs, P. falciparum mono-infection 2000 to 200,000/
µl
Exclusion criteria: Severe malaria, any other concomitant illness or underlying disease,
known allergy to study drugs, clear history of adequate antimalarial treatment in the
previous 72 hours, PCV < 15%
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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