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Clinical Trial Results:
Antivirals for influenza Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE

Summary
EudraCT number	2014-004471-23
Trial protocol	HU BE IE GB SE CZ LT DK NL PL
Global end of trial date	09 May 2018

Results information
Results version number	v1(current)
This version publication date	26 Jul 2019
First version publication date	26 Jul 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
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Trial information

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Sponsor protocol code

CB/ALICE/0010

ISRCTN number

ISRCTN27908921

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

University of Oxford

Sponsor organisation address

Block 60 Churchill Hospital, Oxford, United Kingdom, OX3 7LE

Public contact

Prof Chris Butler, University of Oxford, 0044 1865 289363, christopher.butler@phc.ox.ac.uk

Scientific contact

Prof Chris Butler, University of Oxford, 0044 1865 289363, christopher.butler@phc.ox.ac.uk

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

24 Sep 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

09 May 2018

Global end of trial reached?

Yes

Global end of trial date

09 May 2018

Was the trial ended prematurely?

Main objective of the trial

To determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity

Protection of trial subjects

Patients were randomised to either usual care or usual care with oseltamivir treatment. Oseltamivir has a well recorded safety profile with minimal side effects and at the start of the trial was classified by the WHO as an essential medicine that had been stockpiled in many countries to treat and prevent seasonal and pandemic influenza. The Primary Care Clinical Trials Unit (PC-CTU) at the Nuffield Department of Primary Care Health Sciences maintained a dedicated email, answer phone and fax line to allow reporting of all SAEs. Country Co-ordinators ensured the quick follow up of all SAEs within their country, and all SAEs were reported back to the PC-CTU for review by the sponsor and the IDMC. The trial symptom diary was completed between day 0-14 by the trial participants or their legal guardians. This was a fairly significant burden on the participant, but essential to the trial. We made the diary as streamline and easy to complete as possible and only participants that have the time and ability, or where the legal guardian had the time and ability, to complete the diary were asked to join the trial.

Background therapy

Evidence for comparator

General Practitioners in Europe usually advise patients who consult with ILI to take paracetamol or non-steroidal anti-inflammatory agents (NSAIDs), like ibuprofen, either when required or at regular intervals. They may also provide advice about over the counter remedies, maintaining fluids, bed rest and taking time off work. This broad approach is currently considered best practice for the empirical management of influenza like illness (ILI). ALIC4E included a ‘best usual primary care’ arm alone, and best usual primary care with oseltamivir treatment. This allowed the study to determine the added benefit of antiviral agents over and above current practice. This is necessary for answering the question about whether or not it is worth adding antiviral treatment to current practice in European primary care, which is important for informing: antiviral prescribing decisions, patients help seeking, self-care strategies and the provision and configuration of primary care services.

Actual start date of recruitment

15 Jan 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country