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

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Kayentao 2006 MLI (Continued) Outcomes 1. ACPR at days 28, PCR adjusted and unadjusted 2. Mean haemoglobin at days 14 and 28 3. Gametocyte carriage during follow up Not included in this review: 1. Proportion with fever days 0, 1, 2, 3 2. Proportion parasitaemic days 0, 1, 2, 3 Notes Country: Mali Setting: Rural health centre Transmission: Seasonal with peak in October Resistance: CQ Dates: Jul 2005 to Jan 2006 Funding: US Centers for Disease Control and Prevention, Malaria and Research Training Center, University of Bamako Risk of bias Item Authors’ judgement Description Adequate sequence generation? Unclear ’Block randomisation (block size of 20)’. No further details. Allocation concealment? No None described Blinding? All outcomes Incomplete outcome data addressed? All outcomes No Described as ’open-label’. Patients were not informed of the drug received but no placebos were used. Microscopists were unaware of treatment allocation. Yes Low losses to follow up in all groups (1.5% AS+AQ vs 1.5% AS+SP vs 1.5% AQ+SP) Free of selective reporting? Yes All WHO outcomes reported Free of other bias? Yes No other sources of bias identified Kobbe 2007 GHA Methods Trial design: An open label randomized controlled trial Follow up: Standardized history and examination, malaria film and haemoglobin on days 0, 3, 7, 14, and 28 and any other day they felt unwell Adverse event monitoring: ’The comparative tolerability was assessed by the risk of occurrence of an adverse event’. For each adverse event causality was assessed as recommended by the WHO. Participants Number: 246 randomized Inclusion criteria: Age 6 to 59 months, axillary temp > 37.5 ºC or history of fever in the preceding 24 hrs, P. falciparum mono-infection 2000 to 200,000/µl, informed consent Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 70
Kobbe 2007 GHA (Continued) Exclusion criteria: Danger signs or signs of severe malaria, any other severe underlying disease, severe malnutrition, antibiotics or adequate antimalarials in the previous 7 days, a history of hypersensitivity to study drugs, unable to tolerate oral treatment Interventions 1. Artesunate plus amodiaquine, co-blister combination 50 mg AS/153 mg AQ, (Arsucam: Sanofi-Aventis) • 5 to 10 kg AS 1/2 tablet + AQ 1/2 tablet once daily for 3 days • 10 to 21 kg AS 1 tablet + AQ 1 tablet once daily for 3 days • 21 to 40 kg AS 2 tablets + AQ 2 tablets once daily for 3 days 2. Artemether-lumefantrine, fixed dose combination 20/120 mg (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 All doses supervized Outcomes 1. ACPR at day 28, PCR adjusted and unadjusted 2. Haematological recovery at day 28 3. Adverse events Not included in this review: 1. Fever clearance 2. Parasite clearance 3. Parental acceptance of drug therapy Notes Country: Ghana Setting: District Hospital Transmission: Holoendemic with seasonal peaks Resistance: CQ Dates: Oct 2006 to Sept 2007 Funding: Vereinigung der Freunde des Tropeninstituts Hamburg E.V., German Academic Exchange Service. Drugs supplied free of charge by Novartis and Sanofi-Aventis Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’Computer generated list with randomisation in blocks of ten’ Allocation concealment? Yes ’Children received the first dose of the individually allocated treatment (in sealed, numbered, opaque envelopes)’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. No An open label trial. 10% of malaria slides were cross-checked by a blinded microscopist. No Moderate losses to follow up in both groups (14% AL6 vs 16% AS+AQ) 71
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Artemisinin-based combination thera
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Analysis 2.2. Comparison 2 Dihydroa
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Analysis 10.5. Comparison 10 Arteme
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[Intervention Review] Artemisinin-b
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B A C K G R O U N D Malaria is a di
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drugs and the treatment comparisons
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this analysis into participants who
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confidence intervals of the estimat
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or those treated for P. vivax at ba
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Comparison 21. How does Artesunate
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Analysis 6.6. Comparison 6 Artesuna
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Analysis 9.2. Comparison 9 Artemeth
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Analysis 12.2. Comparison 12 Artesu
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Analysis 20.1. Comparison 20 How do
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Analysis 21.1. Comparison 21 How do
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(Continued) 2. How does artesunate
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(Continued) Sensitivity analysis 1
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(Continued) Smithuis 2004 MMR (652
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PCR = polymerase chain reaction PCV
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Footnotes 1 Data were also availabl
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8 Very serious imprecision: There w
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(Continued) justed Vivax efficacy:
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(Continued) Harms: Serious adverse
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(Continued) Harms: Early vomiting -
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1 Dorsey 2006 UGA; Faye 2003 SEN; K
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