Celebrating Success: Major Achievement in COMBACTE-CARE

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POS-VAP Site Selection Completed

CLIN-Net supported the site selection process for the POS-VAP (Perpetual Observational Study on Ventilator Associated Pneumonia). Forty sites in 12 countries were selected for participation.

POS-VAP

The primary objective of the POS-VAP (Perpetual Observational Study on Ventilator Associated Pneumonia) is to build a sustainable European clinical research network of ICUs to provide an infrastructure capable of rapidly implementing randomised controlled trials (RCTs) and other clinical trials related to the prevention, diagnosis or treatment of VAP. Over the three-year duration of the project, 20,000 adult patients at risk of developing VAP are expected to be enrolled at 40 ICU sites across Europe. The building and strengthening of the network during these 3 years should guarantee the continuation of activities beyond this time, in a perpetual manner.

 

Site Selection

CLIN-Net supported the site selection process for the POS-VAP and put forward its network of experienced clinical trial sites.  Through a transparent site selection process, 40 sites and 3 backup in 12 countries were officially selected for participation. As part of COMBACTE, well-performing HONEST-PREPS sites also had the opportunity to transition to POS-VAP with the prospect of joining future Randomized Controlled Trials. Eight sites out of the 40 selected sites previously participated in HONEST-PREPS.

Currently, national regulatory approval has been received for five countries, and seven Site Initiation Visits (SIVs) have been performed. Five sites have been activated, with three sites actively recruiting. Current study activities are centered on regulatory submissions and conciliation of contract details for signature with the sites. The aim is to finalize site activation before summer 2023.

  • "This site selection taught me that there’s no single strategy that works best, and that collective effort and continuous communication are the greatest factors for success."

    Ana C. Hernandez, Coordinating Investigator POS-VAP

Ventilator-Associated Pneumonia

Ventilator-Associated Pneumonia (VAP) is a frequent complication in mechanically-ventilated ICU patients and is often caused by multi-drug resistant bacteria. Distinguishing bacterial colonisation of the respiratory tract from infection of the lung tissue is extremely difficult with currently available diagnostic approaches, resulting in an unnecessary use of broad-spectrum antibiotics in many patients, thereby enhancing antimicrobial resistance (AMR).

About ECRAID-Base

POS-VAP is one of the Perpetual Observational Studies (POS) within ECRAID-Base. 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. Ecraid is the envisaged, long-term successor of COMBACTE and other European-funded projects such as PREPARE.

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