Ecraid's laboratory network LAB-Net plays a key role in the site selection process in most ECRAID-Base studies, including POS-VAP (Perpetual Observational Study on Ventilator Associated Pneumonia). The study's main goal is to build a sustainable European clinical research network of ICUs. This will serve as a platform to facilitate observational and randomized VAP research activities. Over the five-year duration of the project, 20,000 patients are expected to be enrolled at 40 ICU sites in 15 European countries.
POS-VAP enrolled its first patient in August 2022 at the University Hospital of Limoges, and is on track to expand patient inclusion soon.
LAB-Net undertakes various tasks within the study. Through a transparent ongoing site selection process, 39 sites have been selected to date. General laboratory questions were included in the clinical questionnaire, with more specific ones sent to selected sites. Once there are at least five sites actively enrolling patients, laboratories from these sites will receive an invitation to participate in an External Quality Assessment (EQA) organised and conducted by LAB-Net. The results from both activities, the questionnaire and the EQA panel, will serve as a starting point for LAB-Net to prepare and conduct tailored trainings for the participating sites.
The laboratory network's team took the lead in designing a general microbiology questionnaire to collect data about clinical samples collected within the different POS. This form has been integrated in the electronic Case Report Form (eCRF). In order to reduce the workload per POS, the general form can be adapted for each study. For POS-VAP, dedicated questions about sample types, tests, species identification and antimicrobial susceptibility results relevant for VAP have been added.
The activities of LAB-Net within POS-VAP mostly revolve around training and EQA. LAB-Net will continue training on appropriate sampling and screening methods for VAP diagnostics. It will plan and carry out EQA exercises as well. Identifying the most common respiratory pathogens and antimicrobial susceptibility testing had to be done for EQA purposes. LAB-Net focused particularly on detecting and reporting common antimicrobial resistance of clinical and epidemiological importance. So far, these different activities have been conducted at seven sites that previously participated in a study conducted under the COMBACTE project (HONEST-PREPS), also focused on VAP. The quality of the microbiological laboratories at these sites was confirmed through EQA, after which high-quality sites were selected for POS-VAP. Certificates, general and individual results were sent to participants at the end of June 2022.
The EU-funded ECRAID-Base project delivers the initial set of activities for Ecraid. Over the five-year duration of the project, Ecraid will evolve into a self-sustainable not-for-profit organisation aiming to improve clinical research in the field of infectious diseases in Europe.
At the heart of ECRAID-Base is the unification of several networks into one centralised sustainable network that shares resources, data and expertise to tackle the most urgent infectious diseases threats. Its infrastructure – built within the EU-funded projects COMBACTE and PREPARE – facilitates faster, easier and more cost-effective clinical research. The first studies to benefit from this unified infrastructure are five Perpetual Observational Studies (POS). All of these will mature towards adaptive platform trials, with the capability to rapidly respond to public health threats.