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

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Kayentao 2006 MLI (Continued)<br />

Outcomes 1. ACPR at days 28, PCR adjusted and unadjusted<br />

2. Mean haemoglobin at days 14 and 28<br />

3. Gametocyte carriage during follow up<br />

Not included in this review:<br />

1. Proportion with fever days 0, 1, 2, 3<br />

2. Proportion parasitaemic days 0, 1, 2, 3<br />

Notes Country: Mali<br />

Setting: Rural health centre<br />

Transmission: Seasonal with peak in October<br />

Resistance: CQ<br />

Dates: Jul 2005 to Jan 2006<br />

Funding: US Centers <strong>for</strong> Disease Control and Prevention, Malaria and Research Training<br />

Center, University of Bamako<br />

Risk of bias<br />

Item Authors’ judgement Description<br />

Adequate sequence generation? Unclear ’Block randomisation (block size of 20)’.<br />

No further details.<br />

Allocation concealment? No None described<br />

Blinding?<br />

All outcomes<br />

Incomplete outcome data addressed?<br />

All outcomes<br />

No Described as ’open-label’. Patients were not<br />

in<strong>for</strong>med of the drug received but no placebos<br />

were used. Microscopists were unaware<br />

of treatment allocation.<br />

Yes Low losses to follow up in all groups (1.5%<br />

AS+AQ vs 1.5% AS+SP vs 1.5% AQ+SP)<br />

Free of selective reporting? Yes All WHO outcomes reported<br />

Free of other bias? Yes No other sources of bias identified<br />

Kobbe 2007 GHA<br />

Methods Trial design: An open label randomized controlled trial<br />

Follow up: Standardized history and examination, malaria film and haemoglobin on<br />

days 0, 3, 7, 14, and 28 and any other day they felt unwell<br />

Adverse event monitoring: ’<strong>The</strong> comparative tolerability was assessed by the risk of occurrence<br />

of an adverse event’. For each adverse event causality was assessed as recommended<br />

by the WHO.<br />

Participants Number: 246 randomized<br />

Inclusion criteria: Age 6 to 59 months, axillary temp > 37.5 ºC or history of fever in the<br />

preceding 24 hrs, P. falciparum mono-infection 2000 to 200,000/µl, in<strong>for</strong>med consent<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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