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

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Falade 2005 NGA (Continued) Camoquine: Pfizer) • AS 4 mg/kg once daily for 3 days • AQ 10 mg/kg once daily for 3 days All doses supervized and given with food, fruit drink, or dissolved in water Outcomes 1. ACPR at day 28, PCR adjusted and unadjusted 2. Haematocrit on days 0, 7, and 28 3. Adverse events, including mean WBC and liver enzymes Not included in the review: 1. Fever clearance time 2. Parasite clearance time Notes Country: Nigeria Setting: General Outpatient Department of University College Hospital Transmission: Intense and occurs all year round Resistance: CQ and SP Dates: Aug 2004 to Aug 2005 Funding: Study meds were supplied by Novartis, Sanofi-Sycitilabo and Pfizer Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’A pregenerated randomisation table’ Allocation concealment? No None described Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open label trial. No comment on blinding of lab staff Yes Low losses to follow up in both groups (7.5% AL6 vs 6.0% AS+AQ) Free of selective reporting? Yes All WHO outcomes reported. The WHO recommends 42 days follow up in studies of AL6. Day 28 outcomes may under estimate treatment failure with AL6. Free of other bias? Yes No other sources of bias identified Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 52
Fanello 2004 RWA Methods Trial design: An open-label randomized controlled trial Follow up: Participants were admitted to hospital for the first 3 days then seen at days 7, 14, 21, and 28. At each visit history, clinical signs and symptoms, temperature and malaria film. PCV and WBC were recorded on days 0 and 14. Adverse event monitoring: All adverse events were recorded on the clinical record form and a causality assessment was made Participants Number: 500 randomized Inclusion criteria: Age 12 to 59 months, weight >10 kg, axillary temp > 37.5 ºC or history of fever in the previous 24 hrs, P. falciparum mono-infection 2000 to 200,000/ µl, informed consent Exclusion criteria: Severe malaria, concomitant illness or underlying disease, known allergy to the study drugs, a clear history of adequate antimalarial treatment in the previous 72 hrs Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets • < 15 kg 1 tablet twice daily for 3 days • 15 to 24 kg 2 tablets twice daily for 3 days 2. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination • AQ 10 mg/kg once daily for 3 days • SP 25/1.25 mg/kg on day 0 All doses supervized Outcomes 1. ACPR at day 28, PCR adjusted and unadjusted 2. Gametocyte carriage during follow up 3. Mean PCV at days 0 and 14 4. Adverse events, including mean WBC at days 0 and 14 Not included in the review: 1. Fever clearance 2. Parasite clearance Notes Country: Rwanda Setting: Rural health clinics Transmission: Variable Resistance: Not described Dates: July 2004 to Dec 2004 Funding: Belgian Development Co-operation (DGIS) and the Prince Leopold Institute of Tropical Medicine Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’Randomly allocated in blocks of 20...according to a randomization list prepared in Belgium’ Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 53
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1 Dorsey 2006 UGA; Faye 2003 SEN; K
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