TY - JOUR
T1 - Antivirals for influenza-Like Illness?
T2 - A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC E): the ALIC E protocol
AU - van der Velden, Alike W
AU - Bongard, Emily
AU - Cook, Johanna
AU - Saville, Ben
AU - Beutels, Philippe
AU - Munck Aabenhus, Rune
AU - Brugman, Curt
AU - Chlabicz, Slawomir
AU - Coenen, Samuel
AU - Colliers, Annelies
AU - Davies, Melanie
AU - De Paor, Muireann
AU - De Sutter, An
AU - Francis, Nick A
AU - Glinz, Dominik
AU - Godycki-Ćwirko, Maciek
AU - Goossens, Herman
AU - Holmes, Jane
AU - Ieven, Margareta
AU - de Jong, Menno
AU - Lindbaek, Morten
AU - Little, Paul
AU - Martinón-Torres, Frederico
AU - Moragas, Ana
AU - Pauer, József
AU - Pfeiferová, Markéta
AU - Radzeviciene-Jurgute, Ruta
AU - Sundvall, Pär-Daniel
AU - Torres, Antoni
AU - Touboul, Pia
AU - Varthalis, Dionyssios
AU - Verheij, Theo
AU - Butler, Christopher C
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2018/7/12
Y1 - 2018/7/12
N2 - 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.
AB - 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.
KW - adaptive clinical trial
KW - cost-benefit analysis
KW - influenza
KW - oseltamivir
KW - primary healthcare
U2 - 10.1136/bmjopen-2017-021032
DO - 10.1136/bmjopen-2017-021032
M3 - Article
C2 - 30002007
SN - 2044-6055
VL - 8
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e02103
ER -