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Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC4E): the ALIC4E protocol

Bongard, Emily, van der Velden, Alike W, Cook, Johanna, Saville, Ben, Beutels, Philippe, Munck Aabenhus, Rune, Brugman, Curt, Chlabicz, Slawomir, Coenen, Samuel, Colliers, Annelies, Davies, Melanie, De Paor, Muireann, De Sutter, An, Francis, Nick A, Glinz, Dominik, Godycki-?wirko, Maciek, Goossens, Herman, Holmes, Jane, Ieven, Margareta, de Jong, Menno, Lindbaek, Morten, Little, Paul, Martinón-Torres, Frederico, Moragas, Ana, Pauer, József, Pfeiferová, Markéta, Radzeviciene-Jurgute, Ruta, Sundvall, Pär-Daniel, Torres, Antoni, Touboul, Pia, Varthalis, Dionyssios, Verheij, Theo and Butler, Christopher C 2018. Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC4E): the ALIC4E protocol. BMJ Open 8 (7) , e021032. 10.1136/bmjopen-2017-021032

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Abstract

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.

Item Type: Article
Date Type: Published Online
Status: Published
Schools: Medicine
Publisher: BMJ Publishing Group: Open Access / BMJ Journals
ISSN: 2044-6055
Funders: EU FP7
Date of First Compliant Deposit: 2 August 2018
Date of Acceptance: 14 June 2018
Last Modified: 08 Aug 2018 10:15
URI: http://orca.cf.ac.uk/id/eprint/113871

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