Antivirale middelen voor griep(-achtige) klachten? Een gerandomiseerd klinisch onderzoek naar de (kosten) effectiviteit in de eerstelijnszorg (ALICE).

Title: Antivirals for influenza-Like Illness? An rCt of Clinical and Cost
effectiveness in primary CarE (ALICE)

Given the findings of a reduction of 0.5 to 1 day in the time to first
alleviation of symptoms from treatment of ILI (influenza-Like Illness) with
antivirals, important questions remain:
Does this effect found in efficacy studies translate into meaningful benefit in
every day primary care? Specifically, what are the overall costs and benefits
of this shortened symptom duration from the perspective of the individual
sufferer, for the health services, and for society? Or do patients considered
to be at higher risk from complications of influenza (due to age or
co-morbidity for example) receive additional benefit from antiviral treatment
in primary care?

Answering these questions will reduce important clinical uncertainty for
primary care clinicians about whether to prescribe antiviral agents for ILI.

ALICE is a randomised controlled trial in Primary Care that aims to determine
whether adding antiviral treatment to best usual primary care is effective in
reducing time to return to usual daily activity and so the clinical and cost
effectiveness of adding antiviral agents to best usual primary care of people
suffering from influenza-like illness (ILI).

The ALICE trial is a open, prospective, international, non-industry sponsored,
pragmatic randomised controlled trial in Primary Care. The trial will be
executed in approximately 20 European primary care networks. An adaptive trial
design will be used to test the study hypothesis.

ALICE will be initiated with two open, intervention arms with patient assignment by remote randomisation: 1. Oseltamivir, in the recommended doses for children and adults, with best usual primary care 2. Best usual primary care Those whom the responsible clinician considers should receive immediate treatment with antiviral agents will not be eligible for the trial (this is one of the exclusion criteria).

All patients will complete a symptom diary for 2 weeks (this may take up to 5
minutes every day). At baseline patients aged <16 will have an oropharyngeal
and nasal swab taken. Those >=16 will have a nasopharyngeal swab taken. Around
day 3, day 14 and after one 1 month the patients will be contacted by telephone
to complete a short questionnaire.
There are some common side effects when taking Oseltamivir, such as a headache
and nausea. Some of the less common side effects include dizziness, fatigue ,
abdominal pain and insomnia.
There are no guaranteed benefits from taking part. However, this study aims to
improve the treatment of flu-like illnesses in the future.