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

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Karema 2004 RWA (Continued) Free of selective reporting? Yes All WHO outcomes reported. Day 28 outcomes may underestimate failure with DHA-P due to its long half-life. Free of other bias? Yes No other sources of bias identified Karunajeewa 2007 PNG Methods Trial design: A 4-arm open label randomized controlled trial Follow up: Standardized follow up including temperature and malaria film on days 0, 1, 2, 3, 7, 14, 28, and 42. Drug levels assayed on day 7. Adverse event monitoring: None described Participants Number: 372 randomized to included treatment arms Inclusion criteria: Age 0.5 to 5 years, axillary temp > 37.5 ºC or history of fever in the preceding 24 hrs, > 1000/µl asexual P. falciparum or > 250/µl asexual P. vivax, P. ovale or P. malariae, informed consent Exclusion criteria: Features of severe malaria, evidence of another infection or coexisting condition including malnutrition, intake of study drug in previous 14 days Interventions 1. Artesunate plus sulfadoxine-pyrimethamine, loose combination (Sanofi-Aventis, Roche) • AS 4 mg/kg once daily for 3 days • SP 25/1.25 mg/kg once on the first day 2. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets (Beijing Holley-Cotec) • DHA 2.5 mg/kg once daily for 3 days • P 20 mg/kg once daily for 3 days 3. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Novartis), given with milk • A 1.7 mg/kg twice daily for 3 days • L 10 mg/kg twice daily for 3 day All doses supervized except the evening dose of AL6 Outcomes 1. ACPR (P. falciparum) at days 28 and 42, PCR adjusted and unadjusted 2. ACPR (P. vivax) at day 42 3. Gametocyte prevalence during follow up 4. Adverse events Not included in this review: 1. Fever clearance 2. Parasite clearance 3. Drug levels day 7 Notes Country: Papua New Guinea Setting: Health centres Transmission: Holoendemic Resistance: CQ and SP Dates: Apr 2005 to Jul 2007 Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 68
Karunajeewa 2007 PNG (Continued) Risk of bias Funding: WHO Western Pacific Region, Rotary against Malaria in Papua New Guinea, National Health and Medical Research Council of Australia Item Authors’ judgement Description Adequate sequence generation? Yes ’Computer-generated randomised assignment with blocks of 24 for each site’ Allocation concealment? No Not described Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open label trial. Microscopists were unaware of treatment assignments. Yes Moderate losses to follow up in all groups (11.5% AS+SP vs 13.0% DHA-P vs 14.2% AL6) Free of selective reporting? Yes All WHO outcomes reported. Day 42 outcomes may underestimate failure with DHA-P due to its long half-life. Free of other bias? Yes No other sources of bias identified Kayentao 2006 MLI Methods Trial design: An open label 3-arm randomized controlled trial Follow up: Assessment and malaria film on days 0, 1, 2, 7, 14, and 28. Haemoglobin on days 0, 14, 28 or day of failure. Adverse event monitoring: None described Participants Number: 397 randomized Inclusion criteria: Age 6 to 59 months, axillary temp > 37.5 ºC, P. falciparum monoinfection of 2000 to 200,000/µl, informed consent Exclusion criteria: Danger signs, evidence of another febrile illness, haemoglobin < 5 g/dl Interventions 1. Artesunate plus amodiaquine, loose combination • AS 4 mg/kg once daily for 3 days • AQ 10 mg/kg once daily for 3 days 2. Artesunate plus sulfadoxine-pyrimethamine, loose combination • AS 4 mg/kg once daily for 3 days • SP 25/1.25 mg/kg once on the first day 3. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination • AQ 10 mg/kg once daily for 3 days • SP 25/1.25 mg/kg once on the first day All doses supervized Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 69
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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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Figure 1. Methodological quality su
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confidence intervals of the estimat
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Anaemia Hasugian 2005 IDN found tha
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Comparison 12. Artesunate plus amod
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5.2 DHA-P 3 doses 3 1116 Risk Ratio
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Comparison 21. How does Artesunate
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Analysis 1.12. Comparison 1 Dihydro
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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 9.8. Comparison 9 Artemeth
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Analysis 12.2. Comparison 12 Artesu
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Analysis 14.2. Comparison 14 Dihydr
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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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Dihydroartemisinin-piperaquine vs A
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PCR = polymerase chain reaction PCV
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(Continued) Proportion with anaemia
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(Continued) Efficacy: Total Failure
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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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