4. PRACTICE B: Interventional Trial ILI in Primary Car –workpackage 4

European multi-centre open, adaptive-platform randomised controlled interventional trial on Influenza-Like-Illness (ILI) in Primary Care (PC).

ALIC4E: ‘Antivirals for influenza Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE 

Individually randomised, open clinical trial (in an adaptive design) comparing the clinical and cost effectiveness of oseltamivir with usual care on duration and control of symptoms in patients presenting to primary care with ILI. At least 4500 participants aged one year or older, presenting with ILI in primary care will be recruited over three winter seasons during times of confirmed, high influenza incidence. Patient randomisation will be remote from the treating clinician and stratified by country and age group (1 to ≤11, 12 to ≤65, >65 years of age).
POCT diagnostic sub-study: The predictive values, sensitivity, specificity and added diagnostic performance characteristics of a novel POCT, the IDYLLA Biocartis platform, will be determined in the laboratory using data and samples from recruited participants.

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Key Objectives

  1. To inform evidence-based guidelines for primary healthcare management of patients presenting with influenza-like illness;
  2. To assess the most effective as well as cost-effective treatment of patients presenting to primary care with ILI, with specific attention for subgroup of patients (age, severity, comorbidity, high-risk). In the first winter influenza season (2015/2016), oseltamivir and best usual care will be evaluated. However, the trial design allows for adding in and dropping interventions (trial arms) in subsequent influenza seasons;
  3. To assess the diagnostic performance of a novel point of care test (POCT) for diagnosing viral respiratory infections in PC;
  4. To make recommendations for safe, rapid, effective inter- and intra- pandemic clinical infections research in PC.

Key tasks

Write protocol and design all associated documents
Set up adaptive design simulations
Source and distribute medication
Obtain ethical, all other required approvals in all countries WP4 will be working in
Recruit and train network leads in each country
Enable recruitment of sites in each country
Manage recruitment of all participants

Team members

Chris Butler Co-ordinator
Theo Verheij Co-investigator
Johanna Cook Senior Trial Manager
Alike van der Velden Network Co-ordinator

Contact us

Coordinator:

Herman Goossens

Herman.Goossens@uza.be

Deputy Coordinator:

Menno de Jong

m.d.dejong@amc.uva.nl

prepare@uantwerpen.be

Partners

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