What we know about treating seasonal influenza
Each year, seasonal influenza causes increased morbidity, decreased work productivity, increased work load on doctors, associated healthcare costs and in some cases, hospitalisation and even mortality. Currently, most European primary care services promote self-care for patients with influenza-like illness (ILI), while in USA and Japan, antiviral treatment with neuraminidase inhibitors is common.
What we are not sure about
When reflecting on the H1N1 pandemic, primary care clinicians and public health physicians often ask whether the liberal use of oseltamivir was justified and whether diagnosis based on symptoms, as opposed to point-of-care testing to guide treatment, is the most cost-effective strategy. While there is some evidence from trials sponsored by pharmaceutical companies of the effectiveness of neuraminidase inhibitors in reducing the illness duration of patients infected with influenza and perhaps in decreasing complications, the evidence is not convincing and a number of questions still remain.
What this trial is exploring
The primary objective of the ALIC4E trial is to determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity. It will also investigate the clinical cost and effectiveness of the addition of antivirals to usual care initially oseltamivir, but the adaptive design will allow the addition of new antiviral throughout the 3 years of the trial. The study will also look at sub-groups and how they respond to different treatments allowing analysis throughout the trial. A qualitative research component will review barriers to recruitment in infectious disease research.
Study design and recruitment
ALICE is a large-scale, international, publically-funded pragmatic, unblinded, individually-randomised controlled trial, being conducted in primary care in 18 European countries simultaneously, including in Ireland. Recruitment is taking place at general practices in each country during the officially-declared flu season, over three years, with a target recruitment of over 4,000 patients.
What does participation involve?
Patients presenting with flu-like symptoms at the practices involved in the trial who agree to participate in this study are randomised to either intervention or control group. The control group receive best usual primary care and antiviral treatment is added to best usual primary care in the intervention group.
For more information
The trial is sponsored by the University of Oxford and is funded by the European Union. The ALIC4E trial is being delivered as work package of the Platform for European Preparedness Against (Re-) emerging Epidemics (PREPARE) consortium grant. PREPARE is a European Commission funded network for the rapid and efficient delivery of harmonised, large-scale clinical research studies on infectious diseases. Dr. Muireann dePaor at the RCSI, Dublin is coordinating the Irish component of the trial.