About: Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC(4) E): the ALIC(4) E protocol

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About: Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC(4) E): the ALIC(4) E protocol Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC(4) E): the ALIC(4) E protocol
Creator	Goossens, Herman Ieven, Margareta Beutels, Philippe Little, Paul De Jong, Menno Coenen, Samuel Brugman, Curt Verheij, Theo Butler, Christopher Aabenhus, Rune Bongard, Emily Chlabicz, Slawomir Colliers, Annelies Cook, Johanna Davies, Melanie De Paor, Muireann De Sutter, An Francis, Nick Glinz, Dominik Godycki-Ćwirko, Maciek Holmes, Jane Lindbaek, Morten Martinón-Torres, Frederico Moragas, Ana Pauer, József Pfeiferová, Markéta Radzeviciene-Jurgute, Ruta Saville, Ben Van Der Velden, Alike
Source	Medline; PMC
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. 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.
has issue date	2018-07-12(xsd:dateTime)
bibo:doi	10.1136/bmjopen-2017-021032
bibo:pmid	30002007
has license	cc-by-nc
sha1sum (hex)	480e5240848f603d3c04a1e21cecfe502a13cd89
schema:url	https://doi.org/10.1136/bmjopen-2017-021032
resource representing a document's title	Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC(4) E): the ALIC(4) E protocol
has PubMed Central identifier	PMC6089276
has PubMed identifier	30002007
schema:publication	BMJ Open
resource representing a document's body	covid:480e5240848f603d3c04a1e21cecfe502a13cd89#body_text
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