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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Tran 2002 VNM (Continued)<br />
Free of selective reporting? Unclear It is unclear from the paper whether it is<br />
only clinical failure that is being reported<br />
Free of other bias? Yes No other sources of bias identified<br />
Van den Broek 2003a BGD<br />
Methods Trial design: A 3-arm, open label randomized controlled trial<br />
Follow up: Clinical assessment and malaria film on days 0, 1, 2, 3, 7, 14, 21, 28, 35,<br />
and 42 and any other day when feeling ill<br />
P. vivax or P. malariae during follow up were treated with CQ and continued in follow<br />
up<br />
Adverse event monitoring: Possible side effects assessed at each visit<br />
Participants Number: 242 randomized to included treatment arms<br />
Inclusion criteria: Age > 1 yr, history of fever, P. falciparum mono-infection 1000 to<br />
100,000/µl, in<strong>for</strong>med consent<br />
Exclusion criteria: Pregnancy, signs of severe malaria, signs of another febrile illness or<br />
severe illness requiring treatment, Hb < 6 g/dl<br />
Interventions 1. Artemether-lumefantrine, fixed dose <strong>combination</strong>, 20 mg/120 mg tablets (Coartem:<br />
Novartis)<br />
• 2 doses per day <strong>for</strong> 3 days according to weight (no further details).<br />
• Taken with 250 ml of sweetened milk<br />
2. Artesunate plus mefloquine, loose <strong>combination</strong><br />
• AS 4 mg/kg once daily <strong>for</strong> 3 days<br />
• MQ 15 mg/kg on day 0 and 10 mg/kg on day 1<br />
All doses supervized<br />
Outcomes 1. ACPR at day 42, PCR adjusted and unadjusted<br />
2. P. vivax parasitaemia during follow up<br />
3. Gametocyte prevalence at days 0, 3, 7, and 14<br />
4. Adverse events<br />
Notes Country: Bangladesh<br />
Setting: Outpatient clinics<br />
Transmission: High endemicity with a clear seasonal pattern<br />
Resistance: Multiple-drug resistance<br />
Dates: May 2003 to Sept 2003<br />
Funding: Médecins sans Frontières (Holland)<br />
Risk of bias<br />
Item Authors’ judgement Description<br />
Adequate sequence generation? Yes ’Randomisation was done in blocks of 30<br />
by drawing a card from a box’<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 />
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