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

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C H A R A C T E R I S T I C S O F S T U D I E S<br />

Characteristics of included studies [ordered by study ID]<br />

Adjei 2006 GHA<br />

Methods Trial design: A single blind randomized controlled trial<br />

Follow up: Clinical and laboratory assessment on days 0, 1, 2, 3, 7, 14, 28 and then<br />

monthly <strong>for</strong> 1 year<br />

Adverse event monitoring: Assessed at each visit up to 1 year using open questions about<br />

side effects, behavioural and developmental concerns. Neurological examination at each<br />

visit. Audiometry assessment on days 0, 3, 7, 28, and 1 year. WBC, aminotransferase<br />

and total bilirubin at days 0, 3, 7, 14, and 28.<br />

Participants Number: 227 randomized<br />

Inclusion criteria: Age 6 months to 14 yrs, axillary temp > 37.5 ºC, signs and symptoms<br />

of uncomplicated malaria, P. falciparum mono-infection 2000 to 200,000/µl, willingness<br />

to comply with the follow up, in<strong>for</strong>med consent<br />

Exclusion criteria: Signs or symptoms of severe malaria, chronic malnutrition or other<br />

severe disease, known intolerance or allergy to study meds, reported treatment with any<br />

of the study drugs during preceding month<br />

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

Novartis)<br />

• 5 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 amodiaquine, loose <strong>combination</strong> (Plasmotrim: Mepha, Camoquine:<br />

Pfizer)<br />

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

• AQ 10 mg/kg once daily <strong>for</strong> 3 days<br />

Only the first dose each day was supervized<br />

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

2. Adverse events including neurological, biochemical, and audiological events<br />

Not included in this review:<br />

1. Fever clearance<br />

2. Parasite clearance<br />

3. Further episodes of symptomatic malaria in 1 year<br />

Notes Country: Ghana<br />

Setting: Urban primary health facilities<br />

Transmission: Not described<br />

Resistance: AQ<br />

Dates: Oct 2004 to Dec 2006<br />

Funding: Danish Council <strong>for</strong> Development Research, Global Fund <strong>for</strong> AIDS, TB and<br />

Malaria through the National Malaria Control Programme<br />

Risk of bias<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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