Perpetual Observational Study - Ventilator Associated Pneumonia (POS-VAP)

April 12, 2024 updated by: European Clinical Research Alliance for Infectious Diseases (ECRAID)

POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Albania
      • Tirana, Albania
        • Recruiting
        • University Hospital of Trauma
        • Principal Investigator:
          • Silva Leka, Dr.
        • Contact:
          • Silva LEKA, Dr
  • Belgium
      • Bruxelles, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc UCL
        • Contact:
        • Principal Investigator:
          • Jean-Baptiste MESLAND, Dr
      • Gent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Contact:
        • Principal Investigator:
          • Jan DE WAELE, Pr
      • La Louvière, Belgium, 7100
      • Liège, Belgium, 4000
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Liege
        • Contact:
        • Principal Investigator:
          • LAMBERMONT Bernard, Pr
      • Ottignies-Louvain-la-Neuve, Belgium, 1340
        • Active, not recruiting
        • Clinique Saint Pierre Ottignies
  • Croatia
      • Rijeka, Croatia
      • Slavonski Brod, Croatia
        • Recruiting
        • General Hospital "Dr. Josip Benčević" Slavonski Brod
        • Contact:
        • Principal Investigator:
          • Jasminka KOPIC, Dr
      • Zagreb, Croatia
        • Not yet recruiting
        • University Hospital for Infectious Diseases
        • Contact:
        • Contact:
        • Principal Investigator:
          • Branimir GJURASIN, Dr
  • Czechia
  • France
      • Chalon Sur Saône, France, 71100
      • Dijon, France, 21079
        • Recruiting
        • Centre Hospitalier Universitaire Dijon Bourgogne
        • Principal Investigator:
          • Jean Pierre QUENOT, Pr
        • Contact:
      • Le Mans, France, 72000
        • Recruiting
        • Centre Hospitalier de Le Mans
        • Contact:
        • Principal Investigator:
          • Cedric DARREAU, Dr
      • Lille, France, 59035
        • Recruiting
        • Centre Hospitalier Regional Universitaire de Lille
        • Contact:
        • Principal Investigator:
          • Saad NSEIR, Pr
      • Limoges, France, 87000
        • Recruiting
        • Centre Hospitalier Universitaire Dupuytren of Limoges
        • Contact:
        • Principal Investigator:
          • Thomas DAIX, Dr
      • Tours, France, 37000
        • Recruiting
        • Centre Hospitalier Universitaire de Tours
        • Contact:
        • Principal Investigator:
          • Denis GAROT, Dr
  • Germany
      • Leipzig, Germany, 04103
        • Not yet recruiting
        • University Hospital Leipzig
        • Contact:
        • Principal Investigator:
          • Sirak PETROS, Pr
  • Greece
      • Alexandroupolis, Greece, 68100
        • Not yet recruiting
        • University Hospital of Alexandroupolis
        • Contact:
        • Principal Investigator:
          • Vasileios PAPAIOANNOU, Pr
      • Athens, Greece, 10676
      • Athens, Greece, 11527
        • Not yet recruiting
        • Sotiria Thoracic Diseases Hospital of Athens
        • Contact:
        • Principal Investigator:
          • Antonia KOUTSOUKOU, Pr
      • Larissa, Greece, 41334
        • Not yet recruiting
        • General University Hospital of Larissa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Demosthenes MAKRIS, Pr
  • Italy
      • Roma, Italy
        • Not yet recruiting
        • IRCCS Ospedale Policlinico Gemelli
        • Contact:
        • Principal Investigator:
          • Gennaro DE PASCALE, Dr
  • Netherlands
      • Deventer, Netherlands, 7416
        • Recruiting
        • Deventer Ziekenhuis
        • Contact:
        • Principal Investigator:
          • H VAN DEN OEVER, Dr
      • Utrecht, Netherlands, 3584
        • Recruiting
        • University Medical Center Utrecht
        • Contact:
        • Principal Investigator:
          • Olaf CREMER, Pr
        • Sub-Investigator:
          • Lennie DERDE, Dr
  • Romania
      • Bucharest, Romania
        • Recruiting
        • Central Military Emergency University Hospital Dr. Carol Davila
        • Principal Investigator:
          • Dan CORNECI, Pr
        • Contact:
      • Bucharest, Romania
        • Recruiting
        • Elias University Emergency Hospital
        • Principal Investigator:
          • Silvius NEGOITA, Dr
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexandra BARAC, Dr
        • Sub-Investigator:
          • Biljana CAREVIC, Pr
  • Spain
      • Barcelona, Spain, 08035
        • Active, not recruiting
        • Vall D'Hebron University Hospital
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
        • Principal Investigator:
          • Dolores ESCUDERO, Dr
        • Sub-Investigator:
          • Lorena FORCELLEDO, Dr
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
        • Principal Investigator:
          • Rafael LEON LOPEZ, Dr
    • Valencia
      • Burjassot, Valencia, Spain, 46100
        • Recruiting
        • IMED Valencia
        • Contact:
        • Principal Investigator:
          • Mercedes MURCIA ANAYA, Dr
  • United Kingdom
      • Cambridge, United Kingdom
        • Not yet recruiting
        • John V Farman Intensive Care Unit
        • Contact:
        • Principal Investigator:
          • Andrew CONWAY MORRIS, Dr
      • Edinburgh, United Kingdom, EH164SA
        • Not yet recruiting
        • Royal Infirmary of Edinburgh
        • Contact:
        • Principal Investigator:
          • Thomas CRAVEN, Dr
      • Newcastle, United Kingdom, NE14LP
        • Not yet recruiting
        • Royal Victoria Infirmary
        • Contact:
        • Principal Investigator:
          • Thomas HELLYER, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to an ICU, who are under IMV and documented or expected to be under IMV for more than 48 hours are eligible to participate in the study

Description

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, if not possible, by a Legally Authorized Representative of the study patient OR any applicable locally accepted form of consent OR consent waiver allowing data collection and sharing of data according to ECRAID's principles

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Enrolled population

All patients meeting eligibility criteria (Adult patients, under a documented or expected time under mechanical ventilation of at least >48h) and providing one of:

  • Informed consent
  • Hospital level consent
  • Non-objection notice
  • Waiver of consent
VAP population
Subset of the enrolled population fulfilling U.S. Food and Drug Administration (FDA) criteria for VAP diagnosis at any time during the follow up
Microbiologically evaluable VAP population
Subset of the VAP population with a documented causative agent (bronchoalveolar lavage [BAL], endotracheal aspirate [ETA], blood sample, sputum, or pleural fluid) within 48 hours from VAP diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of research sites recruiting patients
Time Frame: 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 patients
4 years
Number of patients recruited in the study
Time Frame: 4 years
2. Total number of patients in the POS-VAP network per analysis population (enrolled population, VAP population and microbiologically evaluable VAP population).
4 years
Number of studies implemented through the network
Time Frame: 4 years
3. Total number of implemented observational studies and RCTs (stratified by domain: prevention, diagnosis and treatment).
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of sites recruiting for an study implemented through the network
Time Frame: 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.
4 years
Proportion of patients enrolled through POS-VAP that are part of a preventive study implemented through the network
Time Frame: 4 years
Proportion (%) of POS-VAP enrolled population included in an embedded preventive study, stratified by observational and interventional embedded studies.
4 years
Proportion of patients enrolled through POS-VAP that are part of a diagnostic study implemented through the network
Time Frame: 4 years
Proportion (%) of POS-VAP enrolled population included in an embedded diagnostic study, stratified by observational and interventional embedded studies.
4 years
Proportion of VAP patients enrolled through POS-VAP that are part of a treatment study implemented through the network
Time Frame: 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.
4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of VAP per 1000 ventilation days
Time Frame: 4 years
Incidence of VAP per 1000 ventilation days, measured among the Enrolled population, overal and per site
4 years
ICU mortality rate in non-VAP patients
Time Frame: 4 years
ICU mortality, measured among the Enrolled population not developping VAP, overal and per site
4 years
Time from intubation until VAP diagnosis (days)
Time Frame: 4 years
Time from start of invasive mechanical ventilation (IMV) until VAP diagnosis (days), measured among the VAP population, overall and per site
4 years
Time under IMV after VAP diagnosis (days)
Time Frame: 4 years
Time under IMV after VAP diagnosis (days), measured among the VAP population, measured overall and per site
4 years
IMV-free days from VAP diagnosis till day 28 after VAP diagnosis (days)
Time Frame: 4 years
IMV-free days from VAP diagnosis till day 28 after VAP diagnosis (days), measured among the VAP population, overall and per site
4 years
Length of ICU stay after VAP diagnosis (days)
Time Frame: 4 years
Length of ICU stay after VAP diagnosis (days), measured among the VAP population, overall and per site
4 years
All-cause mortality at day 28 after VAP diagnosis (%)
Time Frame: 4 years
All-cause mortality at day 28 after VAP diagnosis (%), measured among the VAP population, overall and per site
4 years
ICU mortality rate
Time Frame: 4 years
Mortality rate at ICU discharge, measured among the VAP population, overall and per site
4 years
Resolution of signs and symptoms of VAP between days 7 and 10 from VAP diagnosis (%)
Time Frame: 4 years
Resolution of signs and symptoms of VAP between days 7 and 10 from VAP diagnosis (%), measured among the VAP population, overall and per site
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Clinical Research Alliance for Infectious Diseases (ECRAID)

Collaborators

Centre Hospitalier Universitaire Dupuytren de Limoges (CHUL)
Université de Genève (UNIGE)
University Medical Center Utrecht (UMCU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECRAID-Base POS-VAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data from this study will be used to inform future observational studies and RCTs about expected frequencies of exposures and clinical outcomes and expected recruitment rates for specific patient populations. Furthermore, the data will be used to support simulations to gain insight in the optimal design and required sample size of future RCTs as required for future embedded studies, which will be described in the appendices.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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