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Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC4 E): the ALIC4 E protocol
E. Bongard, AW. van der Velden, J. Cook, B. Saville, P. Beutels, R. Munck Aabenhus, C. Brugman, S. Chlabicz, S. Coenen, A. Colliers, M. Davies, M. De Paor, A. De Sutter, NA. Francis, D. Glinz, M. Godycki-Ćwirko, H. Goossens, J. Holmes, M. Ieven,...
Jazyk angličtina Země Velká Británie
Typ dokumentu protokol klinické studie, časopisecké články, práce podpořená grantem
NLK
Directory of Open Access Journals
od 2011
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od 2011
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od 2011
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od 2011-01-01
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od 2011-01-01
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od 2011-01-01
Nursing & Allied Health Database (ProQuest)
od 2011-01-01
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od 2011-01-01
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od 2011
- MeSH
- analýza nákladů a výnosů MeSH
- antivirové látky ekonomika terapeutické užití MeSH
- bolesti hlavy virologie MeSH
- časové faktory MeSH
- chřipka lidská komplikace farmakoterapie prevence a kontrola MeSH
- činnosti denního života MeSH
- horečka virologie MeSH
- hospitalizace MeSH
- léky bez předpisu terapeutické užití MeSH
- léky na předpis terapeutické užití MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- myalgie virologie MeSH
- oseltamivir ekonomika terapeutické užití MeSH
- péče o sebe MeSH
- pneumonie virologie MeSH
- pragmatické klinické studie jako téma * MeSH
- určení symptomu MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- protokol klinické studie MeSH
INTRODUCTION: Effective management of seasonal and pandemic influenza is a high priority internationally. Guidelines in many countries recommend antiviral treatment for older people and individuals with comorbidity at increased risk of complications. However, antivirals are not often prescribed in primary care in Europe, partly because its clinical and cost effectiveness has been insufficiently demonstrated by non-industry funded and pragmatic studies. METHODS AND ANALYSIS: Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE is a European multinational, multicentre, open-labelled, non-industry funded, pragmatic, adaptive-platform, randomised controlled trial. Initial trial arms will be best usual primary care and best usual primary care plus treatment with oseltamivir for 5 days. We aim to recruit at least 2500 participants ≥1 year presenting with influenza-like illness (ILI), with symptom duration ≤72 hours in primary care over three consecutive periods of confirmed high influenza incidence. Participant outcomes will be followed up to 28 days by diary and telephone. The primary objective is to determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity with fever, headache and muscle ache reduced to minor severity or less. Secondary objectives include estimating cost-effectiveness, benefits in subgroups according to age (<12, 12-64 and >64 years), severity of symptoms at presentation (low, medium and high), comorbidity (yes/no), duration of symptoms (≤48 hours/>48-72 hours), complications (hospital admission and pneumonia), use of additional prescribed medication including antibiotics, use of over-the-counter medicines and self-management of ILI symptoms. ETHICS AND DISSEMINATION: Research ethics committee (REC) approval was granted by the NRES Committee South Central (Oxford B) and Clinical Trial Authority (CTA) approval by The Medicines and Healthcare products Regulatory Agency. All participating countries gained national REC and CTA approval as required. Dissemination of results will be through peer-reviewed scientific journals and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN27908921; Pre-results.
Clinic of Social and Family Medicine University of Crete Heraklion Greece
Department of Family and Community Medicine Medical University of Lodz Lodz Poland
Department of Family Medicine and Community Nursing Medical University of Bialystok Bialystok Poland
Department of Family Medicine and Primary Health Care Ghent University Ghent Belgium
Department of General Practice Institute of Health and Society University of Oslo Oslo Norway
Department of Medical Microbiology Academic Medical Center Amsterdam The Netherlands
Department of Population Medicine Cardiff University School of Medicine Cardiff UK
Drug Research Centre LLC Balatonfüred Hungary
Institute for Public Health University of Copenhagen Copenhagen Denmark
Institute of General Practice 1st Faculty of Medicine Charles University Prague Czech Republic
JSC Mano Seimos Gydytojas Klaipėda Lithuania
Primary Care and Population Science University of Southampton Southampton UK
Primary Healthcare Centre Jaume 1 Universitat Rovira i Virgili Tarragona Catalonia Spain
SERGAS Hospital Clinico Universitario de Santiago de Compostela Santiago de Compostela Spain
The Nuffield Department of Primary Care Health Sciences University of Oxford Oxford UK
Citace poskytuje Crossref.org
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- $a Bongard, Emily $u The Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
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- $a Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC4 E): the ALIC4 E protocol / $c E. Bongard, AW. van der Velden, J. Cook, B. Saville, P. Beutels, R. Munck Aabenhus, C. Brugman, S. Chlabicz, S. Coenen, A. Colliers, M. Davies, M. De Paor, A. De Sutter, NA. Francis, D. Glinz, M. Godycki-Ćwirko, H. Goossens, J. Holmes, M. Ieven, M. de Jong, M. Lindbaek, P. Little, F. Martinón-Torres, A. Moragas, J. Pauer, M. Pfeiferová, R. Radzeviciene-Jurgute, PD. Sundvall, A. Torres, P. Touboul, D. Varthalis, T. Verheij, CC. Butler,
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- $a INTRODUCTION: Effective management of seasonal and pandemic influenza is a high priority internationally. Guidelines in many countries recommend antiviral treatment for older people and individuals with comorbidity at increased risk of complications. However, antivirals are not often prescribed in primary care in Europe, partly because its clinical and cost effectiveness has been insufficiently demonstrated by non-industry funded and pragmatic studies. METHODS AND ANALYSIS: Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE is a European multinational, multicentre, open-labelled, non-industry funded, pragmatic, adaptive-platform, randomised controlled trial. Initial trial arms will be best usual primary care and best usual primary care plus treatment with oseltamivir for 5 days. We aim to recruit at least 2500 participants ≥1 year presenting with influenza-like illness (ILI), with symptom duration ≤72 hours in primary care over three consecutive periods of confirmed high influenza incidence. Participant outcomes will be followed up to 28 days by diary and telephone. The primary objective is to determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity with fever, headache and muscle ache reduced to minor severity or less. Secondary objectives include estimating cost-effectiveness, benefits in subgroups according to age (<12, 12-64 and >64 years), severity of symptoms at presentation (low, medium and high), comorbidity (yes/no), duration of symptoms (≤48 hours/>48-72 hours), complications (hospital admission and pneumonia), use of additional prescribed medication including antibiotics, use of over-the-counter medicines and self-management of ILI symptoms. ETHICS AND DISSEMINATION: Research ethics committee (REC) approval was granted by the NRES Committee South Central (Oxford B) and Clinical Trial Authority (CTA) approval by The Medicines and Healthcare products Regulatory Agency. All participating countries gained national REC and CTA approval as required. Dissemination of results will be through peer-reviewed scientific journals and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN27908921; Pre-results.
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