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

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Kamya 2006 UGA (Continued) Risk of bias Dates: Mar 2006 to July 2006 Funding: US Centres for Disease Control, Malaria Consortium Drugman, DFID, DHA- P supplied by HolleyPharm Item Authors’ judgement Description Adequate sequence generation? Yes ’A randomisation list was computer generated 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 ’Study physicians and laboratory personnel involved in assessing outcomes were blinded to treatment assignments’ Yes Low losses to follow up in both groups (0.9% AL6 vs 0.9% DHA-P). A large number of participants were excluded after randomization for failing to meet the entry criteria. 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 Karema 2004 RWA Methods Trial design: A 3-arm open label randomized controlled trial Follow up: History, clinical signs and symptoms, and malaria film on days 0, 1, 2, 3, 7, 14, 21, and 28 and any other day they felt unwell. PCV measured at days 0 and 14. Adverse event monitoring: An adverse event defined as any unfavourable and unintended sign associated temporally with the use of the drug administered. Differential WBC count (and liver function tests at 1 site only) assessed at days 0 and 14. Participants Number: 762 randomized Inclusion criteria: Age 12 to 59 months, weight > 10 kg, axillary temp > 37.5 ºC or history of fever in the preceding 24 hrs, P. falciparum mono-infection 2000 to 200,000/ µl Exclusion criteria: Severe malaria, any other concomitant illness or underlying disease, known allergy to study drugs, clear history of adequate antimalarial treatment in the previous 72 hours, PCV < 15% Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 66
Karema 2004 RWA (Continued) Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleypharm) • Total dose: DHA 4.8 to 9.3 mg/kg + P 38.4 to 73.8 mg/kg in 3 divided doses, given once daily for 3 days 2. Artesunate plus amodiaquine, loose combination (Arsumax: Sanofi) • AS 4 mg/kg once daily for 3 days • AQ 10 mg/kg once daily for 3 days 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 Outcomes 1. ACPR at day 28, PCR adjusted and unadjusted 2. Gametocyte prevalence during follow up 3. Mean PCV at baseline and day 14 4. Adverse events Not included in this review: 1. Fever clearance 2. Parasite clearance Notes Country: Rwanda Setting: Peri-urban and rural health centres Transmission: Not reported Resistance: Not reported Dates: Oct 2003 to Apr 2004 Funding: Belgian Development Co-operation in collaboration with the Prince Leopold Institute of Tropical Medicine. DHA-P provided by Holleypharm Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’Randomly allocated in blocks of 15’, computer generated sequence (information from author) Allocation concealment? Unclear ’Allocation of treatment was concealed until final recruitment’. No further details 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. ’Laboratory technicians reading malaria slides did not know the treatment received’ Yes Very low losses to follow up in all groups (0.8% DHA-P vs 0.4% AS+AQ vs 1.2% AQ+SP) 67
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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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Artesunate plus mefloquine vs Amodi
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Artemether-lumefantrine vs Artesuna
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(Continued) Zongo 2005 BFA (521 par
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(Continued) Faye 2003 SEN (521 part
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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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