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
馃嚟馃嚪Zagreb, Croatia
Clinical Hospital Center Rijeka
馃嚟馃嚪Rijeka, Croatia
Clinique Saint Pierre Ottignies
馃嚙馃嚜Ottignies-Louvain-la-Neuve, Belgium
Vall d'Hebr贸n University Hospital
馃嚜馃嚫Barcelona, Spain
Centre Hospitalier de Le Mans
馃嚝馃嚪Le Mans, France
Universitair Ziekenhuis Gent
馃嚙馃嚜Gent, Belgium
H么pital de Jolimont
馃嚙馃嚜La Louvi猫re, Belgium
General Hospital "Dr. Josip Ben膷evi膰" Slavonski Brod
馃嚟馃嚪Slavonski Brod, Croatia
Evangelismos General Hospital of Athens
馃嚞馃嚪Athens, Greece
University Hospital Motol
馃嚚馃嚳Praha, Czechia
IMED Valencia
馃嚜馃嚫Burjassot, Valencia, Spain
John V Farman Intensive Care Unit
馃嚞馃嚙Cambridge, United Kingdom
Sotiria Thoracic Diseases Hospital of Athens
馃嚞馃嚪Athens, Greece
Centre Hospitalier Universitaire de Tours
馃嚝馃嚪Tours, France
General University Hospital of Larissa
馃嚞馃嚪Larissa, Greece
Centre Hospitalier Universitaire Dupuytren of Limoges
馃嚝馃嚪Limoges, France
Hospital Universitario Reina Sofia
馃嚜馃嚫C贸rdoba, Cordoba, Spain
Royal Infirmary of Edinburgh
馃嚞馃嚙Edinburgh, United Kingdom
University Hospital Kralovske Vinohrady
馃嚚馃嚳Vinohrady, Czechia
Centre Hospitalier William Morey
馃嚝馃嚪Chalon Sur Sa么ne, France
Centre Hospitalier R茅gional Universitaire de Lille
馃嚝馃嚪Lille, France
Centre Hospitalier Universitaire Dijon Bourgogne
馃嚝馃嚪Dijon, France
University Hospital of Alexandroupolis
馃嚞馃嚪Alexandroupolis, Greece
IRCCS Ospedale Policlinico Gemelli
馃嚠馃嚬Roma, Italy
University Hospital Leipzig
馃嚛馃嚜Leipzig, Germany
Deventer Ziekenhuis
馃嚦馃嚤Deventer, Netherlands
Hospital Universitario Central de Asturias
馃嚜馃嚫Oviedo, Asturias, Spain
Royal Victoria Infirmary
馃嚞馃嚙Newcastle, United Kingdom
Elias University Emergency Hospital
馃嚪馃嚧Bucharest, Romania
University Hospital of Trauma
馃嚘馃嚤Tirana, Albania
Central Military Emergency University Hospital Dr. Carol Davila
馃嚪馃嚧Bucharest, Romania
University Clinical Center of Serbia
馃嚪馃嚫Belgrade, Serbia
Centre Hospitalier Universitaire de Li猫ge
馃嚙馃嚜Li猫ge, Belgium
Cliniques Universitaires Saint-Luc UCL
馃嚙馃嚜Bruxelles, Belgium
University Medical Center Utrecht
馃嚦馃嚤Utrecht, Netherlands