Perpetual Observational Study - Ventilator Associated Pneumonia
- Conditions
- Ventilator Associated Pneumonia
- Registration Number
- NCT05719259
- Lead Sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20000
Not provided
- Death is deemed to be imminent or inevitable during this hospital admission AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of research sites recruiting patients 4 years POS-VAP' overarching objective is to build a sustainable European clinical research network of ICUs that serves as platform to facilitate observational and randomized VAP research activities.
This objective will be measured by in three ways:
1. Total number of sites in the POS-VAP network that actively recruit patientsNumber of patients recruited in the study 4 years 2. Total number of patients in the POS-VAP network per analysis population (enrolled population, VAP population and microbiologically evaluable VAP population).
Number of studies implemented through the network 4 years 3. Total number of implemented observational studies and RCTs (stratified by domain: prevention, diagnosis and treatment).
- Secondary Outcome Measures
Name Time Method Proportion of sites recruiting for an study implemented through the network 4 years Average proportion of sites actively recruiting for at least one embedded study at any time during the study period, overall and stratified by observational and interventional embedded studies.
Proportion of VAP patients enrolled through POS-VAP that are part of a treatment study implemented through the network 4 years Proportion (%) of POS-VAP VAP population enrolled in at least one embedded treatment study with clinical outcome after VAP as endpoint, stratified by observational and interventional embedded studies.
Proportion of patients enrolled through POS-VAP that are part of a preventive study implemented through the network 4 years Proportion (%) of POS-VAP enrolled population included in an embedded preventive study, stratified by observational and interventional embedded studies.
Proportion of patients enrolled through POS-VAP that are part of a diagnostic study implemented through the network 4 years Proportion (%) of POS-VAP enrolled population included in an embedded diagnostic study, stratified by observational and interventional embedded studies.
Trial Locations
- Locations (35)
University Hospital for Infectious Diseases
🇭🇷Zagreb, Croatia
Clinical Hospital Center Rijeka
🇭🇷Rijeka, Croatia
Clinique Saint Pierre Ottignies
🇧🇪Ottignies-Louvain-la-Neuve, Belgium
Vall d'Hebrón University Hospital
🇪🇸Barcelona, Spain
Centre Hospitalier de Le Mans
🇫🇷Le Mans, France
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Hôpital de Jolimont
🇧🇪La Louvière, Belgium
General Hospital "Dr. Josip Benčević" Slavonski Brod
🇭🇷Slavonski Brod, Croatia
Evangelismos General Hospital of Athens
🇬🇷Athens, Greece
University Hospital Motol
🇨🇿Praha, Czechia
IMED Valencia
🇪🇸Burjassot, Valencia, Spain
John V Farman Intensive Care Unit
🇬🇧Cambridge, United Kingdom
Sotiria Thoracic Diseases Hospital of Athens
🇬🇷Athens, Greece
Centre Hospitalier Universitaire de Tours
🇫🇷Tours, France
General University Hospital of Larissa
🇬🇷Larissa, Greece
Centre Hospitalier Universitaire Dupuytren of Limoges
🇫🇷Limoges, France
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Cordoba, Spain
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
University Hospital Kralovske Vinohrady
🇨🇿Vinohrady, Czechia
Centre Hospitalier William Morey
🇫🇷Chalon Sur Saône, France
Centre Hospitalier Régional Universitaire de Lille
🇫🇷Lille, France
Centre Hospitalier Universitaire Dijon Bourgogne
🇫🇷Dijon, France
University Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Greece
IRCCS Ospedale Policlinico Gemelli
🇮🇹Roma, Italy
University Hospital Leipzig
🇩🇪Leipzig, Germany
Deventer Ziekenhuis
🇳🇱Deventer, Netherlands
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Royal Victoria Infirmary
🇬🇧Newcastle, United Kingdom
Elias University Emergency Hospital
🇷🇴Bucharest, Romania
University Hospital of Trauma
🇦🇱Tirana, Albania
Central Military Emergency University Hospital Dr. Carol Davila
🇷🇴Bucharest, Romania
University Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium
Cliniques Universitaires Saint-Luc UCL
🇧🇪Bruxelles, Belgium
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands