Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05719259

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Trauma, Tirana, Albania

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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:

    • Total number of sites in the POS-VAP network that actively recruit patients
  2. Number of patients recruited in the study

    Time frame: 4 years

    • Total number of patients in the POS-VAP network per analysis population (enrolled population, VAP population and microbiologically evaluable VAP population).
  3. Number of studies implemented through the network

    Time frame: 4 years

    • Total number of implemented observational studies and RCTs (stratified by domain: prevention, diagnosis and treatment).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

Other outcomes

  1. 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

  2. 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

  3. 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. 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

  5. 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

  6. 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

  7. 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

  8. ICU mortality rate

    Time frame: 4 years

    Mortality rate at ICU discharge, measured among the VAP population, overall and per site

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ana HERNANDEZ, MD, PhD

CONTACT

[email protected]

+33 07 65 15 04 00

Bruno FRANCOIS, MD

CONTACT

[email protected]

+33 05 55 05 69 83

Sponsors and collaborators

Lead sponsor

European Clinical Research Alliance for Infectious Diseases (ECRAID)

Other

Collaborators

  • UMC Utrecht
  • University Hospital, Limoges
  • University of Geneva, Switzerland

Registry information

Official study title

POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia

Acronym: POS-VAP

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 8, 2023
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.