Perpetual Observational Study - Ventilator Associated Pneumonia

Last updated: April 12, 2024
Sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pneumonia

Treatment

N/A

Clinical Study ID

NCT05719259
ECRAID-Base POS-VAP
  • Ages > 18
  • All Genders

Study Summary

Ventilator-Associated Pneumonia (VAP) is a bacterial respiratory infection that patients in the Intensive Care Unit (ICU) often get when they cannot breathe for themselves and require mechanical ventilation. It is linked to higher chances of death, a longer stay in the hospital, higher costs, and the use of more antibiotics.

Options to help prevent or treat this disease are in development and will require evaluation in future clinical trials.

The goal of POS-VAP is to build and continuously train a network of ICUs to be prepared for doing these trials, to facilitate their execution.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Age≥18 years
  • At risk of acquiring VAP during ICU stay, defined as:
  • Requiring admission or being admitted to the ICU.
  • Expected or documented to be under IMV for more than 48 hours.
  • Consent, either a written informed consent given by the study patient in full medical,psychological, cognitive, social or legal capacity to give an informed consent, or, ifnot possible, by a Legally Authorized Representative of the study patient OR anyapplicable locally accepted form of consent OR consent waiver allowing data collectionand sharing of data according to ECRAID's principles

Exclusion

Exclusion Criteria:

  • Death is deemed to be imminent or inevitable during this hospital admission AND one ormore of the patient, substitute decision maker or attending physician are notcommitted to full active treatment.

Study Design

Total Participants: 20000
Study Start date:
August 03, 2022
Estimated Completion Date:
March 01, 2026

Study Description

Ventilator associated pneumonia (VAP) is one of the most frequent healthcare associated infections in the Intensive Care Unit (ICU) and a significant burden among ICU patients under invasive mechanical ventilation (IMV).

Several preventive and therapeutic treatment options are being developed in the field of VAP that will require evaluation in future randomized controlled trials (RCTs).

RCTs are the gold standard for evaluating medical interventions but are difficult to perform in a population at risk of, or with, VAP.

These trials are challenging since it is difficult to recruit a large enough volume of high-quality centers to achieve the required number of recruited patients, especially if the focus is on specific patient groups (e.g., VAP due to a specific pathogen), for which site selection can be even more challenging and time consuming. There is a need for a well-organized and well-trained international network of ICUs focusing on VAP research that enables efficient execution of RCTs on diagnostic, preventive and curative interventions in this population.

Through a Perpetual Observational Study (POS) we can provide quick access to a network of sites that fulfill pre-specified criteria. Additionally, the structured network of POS sites within ECRAID will maintain continuous activity to carry out observational studies in this specific field, implementing informed consent (where required), increasing quality and efficiency, and facilitating contracting.

Connect with a study center

  • University Hospital of Trauma

    Tirana,
    Albania

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc UCL

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • Hôpital de Jolimont

    La Louvière, 7100
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000
    Belgium

    Site Not Available

  • Clinique Saint Pierre Ottignies

    Ottignies-Louvain-la-Neuve, 1340
    Belgium

    Site Not Available

  • Clinical Hospital Center Rijeka

    Rijeka,
    Croatia

    Active - Recruiting

  • General Hospital "Dr. Josip Benčević" Slavonski Brod

    Slavonski Brod,
    Croatia

    Active - Recruiting

  • University Hospital for Infectious Diseases

    Zagreb,
    Croatia

    Site Not Available

  • University Hospital Motol

    Praha,
    Czechia

    Active - Recruiting

  • University Hospital Kralovske Vinohrady

    Vinohrady,
    Czechia

    Active - Recruiting

  • Centre Hospitalier William Morey

    Chalon Sur Saône, 71100
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Dijon Bourgogne

    Dijon, 21079
    France

    Active - Recruiting

  • Jean Pierre QUENOT

    Dijon, 21079
    France

    Active - Recruiting

  • Cedric Darraud

    Le Mans, 72000
    France

    Active - Recruiting

  • Centre Hospitalier de Le Mans

    Le Mans, 72000
    France

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire de Lille

    Lille, 59035
    France

    Active - Recruiting

  • Saad NSEIR

    Lille, 59035
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Dupuytren of Limoges

    Limoges, 87000
    France

    Active - Recruiting

  • Thomas DAIX

    Limoges, 87000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Tours

    Tours, 37000
    France

    Active - Recruiting

  • Denis Garot

    Tours, 37000
    France

    Active - Recruiting

  • University Hospital Leipzig

    Leipzig, 04103
    Germany

    Site Not Available

  • University Hospital of Alexandroupolis

    Alexandroupolis, 68100
    Greece

    Site Not Available

  • Evangelismos General Hospital of Athens

    Athens, 10676
    Greece

    Site Not Available

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • General University Hospital of Larissa

    Larissa, 41334
    Greece

    Site Not Available

  • IRCCS Ospedale Policlinico Gemelli

    Roma,
    Italy

    Site Not Available

  • Deventer Ziekenhuis

    Deventer, 7416
    Netherlands

    Active - Recruiting

  • University Medical Center Utrecht

    Utrecht, 3584
    Netherlands

    Active - Recruiting

  • Central Military Emergency University Hospital Dr. Carol Davila

    Bucharest,
    Romania

    Active - Recruiting

  • Elias University Emergency Hospital

    Bucharest,
    Romania

    Active - Recruiting

  • University Clinical Center of Serbia

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, Cordoba 14004
    Spain

    Active - Recruiting

  • IMED Valencia

    Burjassot, Valencia 46100
    Spain

    Active - Recruiting

  • Vall d'Hebrón University Hospital

    Barcelona, 08035
    Spain

    Site Not Available

  • John V Farman Intensive Care Unit

    Cambridge,
    United Kingdom

    Site Not Available

  • Royal Infirmary of Edinburgh

    Edinburgh, EH164SA
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle, NE14LP
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.