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

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$Interventions for treating proximal humeral fractures in adults (Review)$

Grande 2005 PER Methods Trial design: An open-label randomized controlled trial Follow up: Days 0, 1, 2, 3, 7, 14, 21, 28, 35, 42, 49, 56, and 63 or any other day they became ill, for a clinical assessment and malaria film. PCV measurement day 0, 7, 14 and 63. P. vivax treated with CQ. Adverse event monitoring: Assessed at each follow-up visit, an adverse event defined as any unfavourable and unintended sign, symptom or disease temporally associated with the drug administered. Complete blood count, liver, and renal function tests at days 0 and 7. Participants Number: 522 randomized Inclusion criteria: Age 5 to 60 yrs, fever > 37.5 ºC or history of fever in the previous 24 hours, P. falciparum mono-infection 1000 to 200,000/µl Exclusion criteria: Pregnancy or lactation, severe malaria, any concomitant illness or underlying disease, contraindication to any of the trial drugs, history of treatment with mefloquine in the previous 60 days or chloroquine, primaquine or quinine in previous 14 days Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination (Artekin: Holleykin) • Total dose: 6.3 mg/kg DHA and 50.4 mg/kg PQP in 3 divided doses, given once daily for 3 days 2. Artesunate plus mefloquine, loose combination (Artesunate: Guilin, Lariam: Hoffman La-Roche) • AS 4 mg/kg once daily for 3 days • MQ 8 mg/kg once daily for 3 days All doses supervized Outcomes 1. Day 63 cure rate PCR adjusted and unadjusted 2. P. vivax during follow up 3. Gametocyte prevalence at day 0, 7, 14, 21 and 28 4. Gametocyte development during follow up 5. Adverse events Not included in this review: 1. Fever clearance 2. Parasite clearance Notes Country: Peru Setting: 9 rural health posts Transmission: Low malaria transmission Resistance: High CQ and SP resistance Dates: July 2003 to July 2005 Funding: Directorate-General for Development and Cooperation of the Belgian Government Risk of bias Item Authors’ judgement Description Adequate sequence generation? Unclear ’Randomized in blocks of 10’. No further details given. Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 56
Grande 2005 PER (Continued) Allocation concealment? Yes ’Sealed opaque envelopes were opened only after the final decision to recruit the patient had been made’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open-label trial. No comment on blinding of laboratory staff. Yes Similar loss to follow up in both groups (8.7% DHA-P vs 5.9% AS+MQ) Free of selective reporting? Yes All WHO outcomes reported Free of other bias? Yes No other sources of bias identified Guthmann 2003 AGO Methods Trial design: An open label randomized controlled trial Follow up: Reassessed clinically and parasitologically on days 0, 3, 7, 14, 21, and 28. Gametocytes were measured at each visit. Haemoglobin was measured at days 0 and 28. Adverse event monitoring: None described Participants Number: 187 randomized into included treatment arms Inclusion criteria: Age 6 to 59 months, weight > 5 kg, axillary temp > 37.5 ºC or history of fever in the previous 24 hours, P. falciparum mono-infection 2000 to 100,000/µl, living within 1 hours walk of the clinic, informed consent Exclusion criteria: Signs of severity or severe malaria, severe anaemia (Hb < 5 g/dl), severe malnutrition, any concomitant febrile condition with the potential to confound the study outcome, history of allergic reaction to the study drug, reported intake of a full course of antimalarials in the previous 7 days Interventions 1. Artesunate plus amodiaquine, loose combination (Arsumax: Sanofi-Aventis, Camoquin: Parke-Davis) • AS 4 mg/kg once daily for 3 days • AQ 10 mg/kg/day for 3 days 2. Artesunate plus sulfadoxine-pyrimethamine, loose combination (Arsumax: Sanofi- Aventis, Fansidar: Roche) • AS 4 mg/kg once daily for 3 days • SP 25/1.25 mg/kg as a single dose All doses supervized Outcomes 1. Failure at day 28 PCR adjusted 2. Prevalence of anaemia at days 0 and 28 3. Gametocyte carriage at day 28 Notes Country: Angola Setting: Hospital outpatient dept., health centre, 3 health posts and 1 maternal and child health centre Transmission: Mesoendemic with stable and seasonal transmission with a peak from Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 57
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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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D A T A A N D A N A L Y S E S Compa
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Comparison 5. Dihydroartemisinin-pi
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Comparison 21. How does Artesunate
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Analysis 6.6. Comparison 6 Artesuna
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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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PCR = polymerase chain reaction PCV
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Footnotes 1 Data were also availabl
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(Continued) justed Vivax efficacy:
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(Continued) Harms: Serious adverse
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1 Dorsey 2006 UGA; Faye 2003 SEN; K
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