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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Kobbe 2007 GHA (Continued)<br />
Free of selective reporting? Yes All WHO outcomes reported<br />
Free of other bias? Yes No other sources of bias identified<br />
Koram 2003 GHA<br />
Methods Trial design: A 4-arm, open-label randomized controlled trial<br />
Follow up: Examination, symptoms recorded, temperature and pulse and malaria film<br />
on days 0, 1, 2, 3, 7, 14, 21 and 28 and any other day they felt unwell. Full blood count<br />
and haemoglobin measured at days 14 and 28.<br />
Adverse event monitoring: None<br />
Participants Number: 105 randomized into included treatment arms<br />
Inclusion criteria: Age 6 to 59 months, signs and symptoms of uncomplicated malaria<br />
including axillary temp > 37.5 ºC, P. falciparum mono-infection of 2000 to 200,000/µl,<br />
in<strong>for</strong>med consent<br />
Exclusion criteria: Signs and symptoms of severe malaria, other diseases requiring drugs<br />
with antimalarial or antihistaminic activities, Hb < 5 g/dl<br />
Interventions 1. Artemether-lumefantrine, fixed dose <strong>combination</strong>, 20 mg/120 mg tablets (Coartem:<br />
Novartis)<br />
• Twice daily <strong>for</strong> 3 days <strong>based</strong> on weight<br />
2. Artesunate plus amodiaquine, loose <strong>combination</strong><br />
• AS 4 mg/kg/day <strong>for</strong> 3 days<br />
• AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2<br />
All doses supervized<br />
Outcomes 1. ACPR at day 28, PCR adjusted and unadjusted (excluded from primary analysis<br />
due to baseline differences)<br />
2. Gametocyte carriage on days 0, 7, and 14<br />
3. Mean haemoglobin on days 0, 14, and 28<br />
Not included in the review:<br />
1. Fever clearance time<br />
2. Parasite clearance time<br />
Notes Country: Ghana<br />
Setting: Hohoe District Hospital and Navrongo War Memorial Hospital<br />
Transmission: High transmission and markedly seasonal<br />
Resistance: CQ and SP resistance<br />
Dates: June 2003 to Aug 2003<br />
Funding: Multilateral Initiative on Malaria, UNICEF/UNDP/World Bank/WHO Special<br />
Program <strong>for</strong> Research & Training in Tropical Diseases<br />
Risk of bias<br />
Item Authors’ judgement Description<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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