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

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

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 the management of patients presenting with influenza-like illness in PC;
  2. To assess clinical and cost effectiveness of oseltamivir and possibly other antiviral medication for treating patients with ILI in PC;
  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.

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

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