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

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Dorsey 2006 UGA Methods Trial design: A 3-arm, single blind (outcome assessors) randomized controlled trial. An unusual design where participants were randomized to a treatment and followed up through however many episodes of malaria happened to occur during the time period. Follow up: Days 0, 1, 2, 3, 7, 14, and 28 or any other day they became ill, for a standardized history, examination and malaria film. Anthelminthics, iron sulphate, and vitamin A were prescribed as per IMCI guidelines. Participants with P. vivax during follow up were censored on day of occurrence Adverse event monitoring: Assessed at each follow-up visit, an adverse event defined as any untoward medical occurrence. Complete blood count and alanine aminotransferase on day 0 and 14. Participants Number: 329 children randomized to a treatment group Inclusion criteria: Age 1 to 10 yrs, weight >10 kg, agreement to remain in Kampala, agreement to attend the study clinic for any febrile illness, agreement to avoid medications outside of the study, informed consent Exclusion criteria: Known adverse reactions to study meds, severe malnutrition, known serious chronic disease, life threatening lab results on screening Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets • 5 to 14 kg 1 tablet twice daily for 3 days • 15 to 24 kg 2 tablets twice daily for 3 days • 25 to 34 kg 3 tablets twice daily for 3 days 2. Artesunate plus amodiaquine, loose combination • AS 4 mg/kg once daily for 3 days • AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2 • Plus placebo in the evenings 3. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination • AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2 • SP 25/1.25 mg/kg on day 1 • Plus placebo in the evenings Only the first dose was supervized each day Outcomes 1. Risk of treatment failure at day 28, PCR adjusted and unadjusted 2. Recurrent malaria caused by non-falciparum species 3. Gametocyte carriage by day of follow up 4. Mean change in haemoglobin from baseline to day 14 5. Adverse events Not included in the review: 1. Fever clearance 2. Parasite clearance Notes Country: Uganda Setting: Urban clinic Transmission: Mesoendemic with peaks during the 2 rainy seasons Resistance: CQ, AQ and SP resistance Dates: Nov 2004 to June 2006 Funding: National Institutes of Health, Doris Duke Charitable Foundation Risk of bias Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 50
Dorsey 2006 UGA (Continued) Item Authors’ judgement Description Adequate sequence generation? Yes ’A randomisation list was computer generated with variable blocks of 3, 6, and 9 by an off-site investigator’ Allocation concealment? Yes ’Sequentially numbered, sealed envelopes containing the treatment group assignments were prepared from the randomisation list’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes Yes ’All study personnel involved in outcome assessment were blinded to treatment allocation’ Yes Low losses to follow up in all groups and reasons given (2.9% AL6 vs 5.4% AS+AQ vs 5.4% AQ+SP) Free of selective reporting? Yes The WHO recommends 42 days follow-up in studies of AL6. Day 28 outcomes may underestimate the failure rate with AL6. Free of other bias? Yes No other sources of bias identified Falade 2005 NGA Methods Trial design: An open-label randomized controlled trial Follow up: Examination and malaria film on days 0 to 7, 14, 21, and 28. Participants were admitted to hospital for the first 3 days then seen at days 7, 14, 21, and 28. Adverse event monitoring: Assessed at each visit by examination and questioning about the progress of presenting symptoms and new symptoms. FBC, WBC, and liver enzymes on days 0, 7, and 28. An adverse event defined as not present at enrolment but occurring during follow up. Participants Number: 132 participants randomized Inclusion criteria: Age 6 months to 10 yrs, axillary temp > 37.5 ºC, signs and symptoms of malaria, P. falciparum mono-infection 2000 to 200,000/µl, willingness to comply with the protocol, informed consent Exclusion criteria: Signs of severe and complicated malaria or other febrile illness, severe malnutrition, history of hypersensitivity to any of the study drugs Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • 5 to 15 kg 1 tablet twice daily for 3 days • 15 to 25 kg 2 tablets twice daily for 3 days • 25 to 35 kg 3 tablets twice daily for 3 days 2. Artesunate plus amodiaquine, loose combination (Arsumax: Sanofi-Synthelabo, Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 51
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1 Dorsey 2006 UGA; Faye 2003 SEN; K
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