Laboratory of Medical Microbiology

ADEQUATE and PRUDENCE studies: ready for sample shipment

Recruitment for the VALUE-Dx studies, ADEQUATE and PRUDENCE, was successfully concluded in January 2024. Now, LAB-Net is ready to ship the samples from local sites to the central laboratory, following the last patient’s final visit.

About the studies

ADEQUATE and PRUDENCE are studies within the VALUE-Dx consortium that wants to combat antimicrobial resistance (AMR) and improve patient outcomes.

  1. ADEQUATE aims to assess the impact of rapid syndromic diagnostic testing, BioFire® Respiratory Panel 2.1 plus (bioMérieux), in patients with acute respiratory tract infections (ARTI) at the emergency departments of hospitals on admission rates, antimicrobial prescriptions and clinical outcome. ADEQUATE enrolled 520 participants. From a subset of these participants, oropharyngeal swabs were collected on the day of randomisation and on day 30 , as part of a microbiology sub-study.
  2. PRUDENCE wants to determine if point-of-care Community Acquired-ARTI diagnostic (CA-ARTI-Dx) tests could lead to more appropriate prescribing decisions for both upper and lower RTI in community care setting. The selected tests are Abbott AfinionTM CRP (Abbott) and BD VeritorTM System for Influenza A+B (Flu) and for Group A Streptococcus (GAS). PRUDENCE enrolled 2649 participants, with 2240 in the primary care arm and 209 in the long term care facility arm. From 112 participants nasopharyngeal swabs, stool samples and blood samples were taken for the Microbiology-Biomarker sub-study.

Sample collection and management

To ensure qualitative outcomes, it is important that all participating centres align and have clear instructions on procedures. This is where LAB-Net’s central coordination centre becomes pivotal.

  • LAB-Net developed sample collection and management manuals and trained all sites to follow these procedures.
  • LAB-Net provided all investigational sites with the necessary materials for the collection, processing and storage of samples.

Now that all patients are enrolled, the team is ready for the next steps.

  • LAB-Net will ship all samples from the local sites to the central laboratory, where they will be further processed at the University of Antwerp.
  • LAB-Net will biobank the leftovers of the ADEQUATE nasopharyngeal swabs and any remaining samples from the sub-studies after sample analysis.

Sample analysis at the University of Antwerp

  • The Laboratory of Medical Microbiology (LMM) will analyse the oropharyngeal swabs from ADEQUATE using metagenomic sequencing to characterise the influence of antibiotic treatment on the composition of upper respiratory tract microbiome and antimicrobial resistance patterns.
  • The LMM will analyse the nasopharyngeal swabs and stool samples of PRUDENCE using metagenomics to assess whether selection of resistant pathogens occurs under antibiotic pressure. LMM aims to study possible changes in the respiratory and/or the gut microbiome in relation to the type of infection and antibiotics used, as well as to describe the microbial epidemiology of respiratory tract infections.
  • The molecular Pathology group of the Laboratory of Cell Biology and Histology at the University of Antwerp will use whole blood samples, EDTA plasma, and heparin plasma from PRUDENCE to analyse immune and biochemical biomarkers that might allow distinguishing infection from non-infectious causes, differentiating viral and bacterial aetiologies, and predicting prognosis.

ABOUT ADEQUATE-Paediatric and PRUDENCE

ADEQUATE (Advanced Diagnostics for Enhanced QUality of Antibiotic prescription in respiratory Tract infections in Emergency rooms) and PRUDENCE (Platform Randomised controlled trial of point of care Diagnostics for Enhancing the quality of aNtibiotic prescribing for Community acquired acute respiratory tract infection (CA-ARTI) in ambulatory care in Europe) are studies within the VALUE-Dx consortium. VALUE-Dx is the first Innovative Medicines Initiative project initiated by six in vitro diagnostic companies who joined forces with 20 non-industry partners to combat antimicrobial resistance (AMR) and improve patient outcomes.

ADEQUATE aims to assess the impact of rapid syndromic diagnostic testing in patients with Acute Respiratory Tract Infections (ARTI) at the emergency department on  hospital admission rates, antimicrobial prescriptions (days of treatment) and the non-inferiority in terms of clinical outcome.

PRUDENCE aims to determine if having a CA-ARTI diagnostic (CA-ARTI-Dx) test result available when a clinician is considering, or plans to prescribe an antimicrobial, leads to more appropriate prescribing decisions, without causing harm to patients.