Artemisinin-based combination therapy for ... - The Cochrane Library
Artemisinin-based combination therapy for ... - The Cochrane Library
Artemisinin-based combination therapy for ... - The Cochrane Library
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Owusu-Agyei 2006 GHA<br />
Methods Trial design: A 3-arm, randomized controlled trial<br />
Follow up: Participants were assessed <strong>for</strong> adverse events and by malaria film on days 0,<br />
2, 3, 7, 14, and 28 or any other day they were unwell. Haemoglobin measured on days<br />
1, 2, 3, 7, and 28. Anaemia was treated with iron according to national guidelines<br />
Adverse event monitoring: Field workers visited their homes to solicit adverse events on<br />
days 0, 2, 3, 7, 14, and 28<br />
Participants Number: 355 randomized into included treatment arms<br />
Inclusion criteria: Age 6 months to 10 yrs, weight > 5 kg, axillary temp > 37.5 ºC or<br />
history of fever, parasitaemia 2000 to 200,000/µl, in<strong>for</strong>med consent<br />
Exclusion criteria: Danger signs, signs of severe malaria, concomitant febrile illness, Hb<br />
< 7 g/dl<br />
Interventions 1. Artemether-lumefantrine, fixed dose <strong>combination</strong>, 20 mg/120 mg tablets (Coartem:<br />
Novartis)<br />
• Details not given<br />
2. Artesunate plus amodiaquine, co-blistered (Arsucam: Sanofi-Aventis)<br />
• Details not given<br />
All doses supervized <strong>for</strong> 3 days<br />
Outcomes 1. Parasitological and clinical failure at day 28, PCR unadjusted and PCR adjusted<br />
2. Gametocytaemia at day 7<br />
3. Haemoglobin at day 28<br />
4. Adverse events<br />
Notes Country: Ghana<br />
Setting: District hospital<br />
Transmission: Perennial, high with a peak July to August<br />
Resistance: Not stated<br />
Dates: June 2005 to May 2006<br />
Funding: Gates Malaria Partnership of the London School of Hygiene and Tropical<br />
Medicine<br />
Risk of bias<br />
Item Authors’ judgement Description<br />
Adequate sequence generation? Yes ’Randomization was done using Microsoft<br />
Excel 2003 randomisation generator’<br />
Allocation concealment? No None described<br />
Blinding?<br />
All outcomes<br />
Incomplete outcome data addressed?<br />
All outcomes<br />
<strong>Artemisinin</strong>-<strong>based</strong> <strong>combination</strong> <strong>therapy</strong> <strong>for</strong> treating uncomplicated malaria (Review)<br />
Copyright © 2009 <strong>The</strong> <strong>Cochrane</strong> Collaboration. Published by John Wiley & Sons, Ltd.<br />
No An open label trial. No comment on blinding<br />
of lab staff.<br />
Yes Moderate losses to follow up but similar in<br />
both groups (14% AL6 vs 15% AS+AQ)<br />
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