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

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Stohrer 2003 LAO<br />

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

Follow up: A history, axillary temperature and malaria film on days 0, 1, 2, 3, 7, 14, 21,<br />

28, and 42 or other times if they were unwell. Haemoglobin was measured on days 0<br />

and 28<br />

Participants experiencing P. vivax during follow up were withdrawn<br />

Adverse event monitoring: Treatment emergent symptoms and signs were recorded on<br />

days 0 to 3<br />

Participants Number: 108 randomized<br />

Inclusion criteria: Weight > 10 kg, axillary temperature > 37.5 ºC, P. falciparum monoinfection<br />

1000 to 100,000/µl, ability to attend follow up, in<strong>for</strong>med consent<br />

Exclusion criteria: Pregnancy or lactation, signs of severe or complicated malaria, severe<br />

malnutrition, febrile diseases other than malaria, history of hypersensitivity reaction to<br />

any of the study drugs<br />

Interventions 1. Artemether-lumefantrine, fixed dose <strong>combination</strong>, 20 mg/120 mg tablets (Coartem:<br />

Novartis)<br />

• 10 to 14 kg 1 tablet twice daily <strong>for</strong> 3 days<br />

• 15 to 24 kg 2 tablets twice daily <strong>for</strong> 3 days<br />

• 25 to 34 kg 3 tablets twice daily <strong>for</strong> 3 days<br />

• > 35 kg 4 tablets twice daily <strong>for</strong> 3 days<br />

2, Artesunate plus mefloquine, loose <strong>combination</strong> (Plasmotrim: Mepha, Mephaquine:<br />

Mepha)<br />

• AS 4 mg/kg once daily <strong>for</strong> 3 days<br />

• MQ 15 mg/kg on day 1 and 10 mg/kg on day 2<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 carriage at day 7<br />

4. Adverse events<br />

Not included in the review:<br />

1. Parasite clearance<br />

Notes Country: Lao People’s Democratic Republic<br />

Setting: Hospital and community <strong>based</strong><br />

Transmission: Perennial with peaks during the rainy season May to Oct<br />

Resistance: CQ and SP resistance<br />

Dates: Oct to Dec 2003<br />

Funding: USAID, mefloquine and artesunate donated by Mepha, Wellcome Trust of<br />

Great Britain<br />

Risk of bias<br />

Item Authors’ judgement Description<br />

Adequate sequence generation? Unclear ’Envelope randomisation’ in blocks of various<br />

sizes, no further details given<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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