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The ALIC4E study has recruited 1,000 participants so far this flu season.

The Oxford-led ALIC4E study has recruited 1,000 participants so far across Europe this flu season, as it investigates the cost-effectiveness of antivirals for influenza-like-illness. © Shutterstock
This is thanks to the hard work and dedication of our primary care research network leads, the doctors, nurses, research professionals, and of course the patients themselves who have agreed to contribute to this landmark study.
- Professor Chris Butler, Study Chief Investigator

A Europe-wide study that will determine the cost-effectiveness of antiviral treatment for influenza-like-illness in primary care has reached a critical milestone of recruiting over 1,000 participants during its second influenza season and over 1,650 patients in total across the first two study seasons.

Led by the University of Oxford’s Primary Care Clinical Trials Unit in partnership with Utrecht University, the Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE (ALIC4E) study aims to discover whether treatment with the antiviral drug, oseltamivir, added to usual clinical care, will be effective in shortening the duration of symptoms affecting usual daily activities. The study will also investigate if any subgroup of patients (for example, children, older people, or those with pre-existing illness) receive particular benefit. The study is being implemented by 21 primary care research networks across 15 European countries.

“Influenza remains a major health problem: each year, many people become quite unwell with it, miss work and school, and are unable to do their usual tasks,” said study Chief-Investigator Chris Butler, Professor of Primary Care in Oxford University’s Nuffield Department of Primary Care Health Sciences. “Some get pneumonia and other complications, and some die from it. There has not been enough independent research into how best to treat it in the community. So, reaching this recruitment goal is an important milestone for the ALIC4E study. This is thanks to the hard work and dedication of our primary care research network leads, the doctors, nurses, research professionals, and of course the patients themselves who have agreed to contribute to this landmark study.”

“Given the challenge of recruiting patients due to the varying prevalence and short recruitment window for influenza across the population, this milestone is definitely one worth celebrating. ALIC4E is already one of the largest prospective randomised studies of an antiviral agent ever conducted in primary care, and it is the only, international, publicly funded study of its kind.”

The routine use of oseltamivir for influenza like illness in general practice would have far reaching consequences for patients, clinicians and health service resources.

“On the one hand, we don’t want to deny treatments to people who will benefit meaningfully from them,” said Professor Butler. “On the other hand, before treatments are taken up into routine general practice or marketed directly to patients, we need to be sure that they are worth taking.  ALIC4E aims to illuminate this issue.”

Outbreaks of the highly-contagious influenza virus reach epidemic proportions across Europe each winter, with the 2009 H1N1 influenza outbreak defined as a pandemic by the World Health Organisation. While the great majority of patients recover from influenza and influenza-like-illness, some can develop complications such as pneumonia, and accounts for many of the excess winter deaths each year.

The ALIC4E trial is part of the European Commission funded PREPARE network, which supports large-scale clinical research studies on infectious disease so health researchers are better prepared to respond to the need to test new treatments during severe influenza outbreaks.

Find out more about ALIC4E here

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