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

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Bousema 2004 KEN (Continued) • SP 25/1.25 mg/kg as a single dose All doses supervized and given with a fatty meal Outcomes 1. Adequate clinical response at day 28, PCR adjusted and unadjusted (excluded from primary analysis) Not included in the review: 1. Gametocytes carriage at days 0 and 7 2. Assessment of infectiousness of participants Notes Country: Kenya Setting: Rural clinic Transmission: High and perennial Resistance: Not reported Dates: Oct to Dec in 2003 and 2004 Funding: Foundation for the Advancement of Tropical Research, Netherlands Organization for Scientif Research, Ter Meulen Fund Risk of bias Item Authors’ judgement Description Adequate sequence generation? No Children were divided in age strata and randomized to different treatment regimens using Excel generated randomization tables. Serious flaws in randomization. Allocation concealment? No None described Blinding? All outcomes Incomplete outcome data addressed? All outcomes Yes ’Other than those administering the medication, all staff engaged in the trial were blinded to allocation’ No Losses to follow up were different between groups with no losses in the AL group (0% AL6 vs 8.0% AS+SP vs 9.4% AQ+SP). This is likely to be related to the different inclusion criteria for AL6. Free of selective reporting? Yes The WHO recommends 42 days follow up in studies of AL6. Day 28 outcomes may underestimate treatment failure with AL6. Free of other bias? No Due to differing inclusion criteria for the 3 arms children in the AL6 group were older, heavier and had higher Hb levels at baseline. This may improve outcome in this group and consequently the AL6 arm was excluded from this review. Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 46
Bukirwa 2005 UGA Methods Trial design: A single blind randomized controlled trial 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. Haemoglobin measurement day 0, 28 or day of failure. Participants with Hb < 10 g/dl given ferrous sulphate and antihelminthic treatment. Adverse event monitoring: Assessed at each follow-up visit, an adverse event defined as any untoward medical occurrence Participants Number: 419 randomized Inclusion criteria: Age 1 to 10 yrs, axillary temp > 37.5 ºC or history of fever in previous 24 hrs, P. falciparum mono-infection 2000 to 200,000/µl, informed consent Exclusion criteria: Danger signs or evidence of severe malaria, evidence of a concomitant febrile illness, repeated vomiting of first dose of medication, history of serious side effects to study drugs Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • 10 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 • > 35 kg 4 tablets twice daily for 3 days 2. Artesunate plus amodiaquine, loose combination (Arsumax: Sanofi-Aventis, Camoquin: Parke-Davis) • AS 4 mg/kg once daily for 3 days • AQ 10 mg/kg on days 0 & 1 and 5 mg/kg on day 2 • Plus placebos in the evening for 3 days All doses supervized Outcomes 1. Risk of recurrent parasitaemia and recurrent symptomatic malaria at day 28, PCR adjusted and unadjusted 2. Gametocytes during follow up 3. Mean change in haemoglobin from baseline to last day of follow up 4. Adverse events Not included in the review: 1. Fever clearance 2. Parasite clearance Notes Country: Uganda Setting: Rural health centre Transmission: High transmission, holoendemic with peaks following 2 rainy seasons Resistance: CQ and SP resistance Dates: Dec 2004 to July 2005. Funding: Centers for Disease Control and Prevention, Association of Schools of Public Health, DfID Risk of bias Item Authors’ judgement Description Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 47
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1 Dorsey 2006 UGA; Faye 2003 SEN; K
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