An observational study in Ventilator Associated Pneumonia, sponsored by European Clinical Research Alliance for Infectious Diseases (ECRAID). Recruiting at 35 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by European Clinical Research Alliance for Infectious Diseases (ECRAID) · Observational
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.
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.
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 170 across 132 observational studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →European Clinical Research Alliance for Infectious Diseases (ECRAID) is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Subset of the enrolled population fulfilling U.S. Food and Drug Administration (FDA) criteria for VAP diagnosis at any time during the follow up
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
Number of research sites recruiting patients
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
Time frame: 4 years
Number of patients recruited in the study
2\. Total number of patients in the POS-VAP network per analysis population (enrolled population, VAP population and microbiologically evaluable VAP population).
Time frame: 4 years
Number of studies implemented through the network
3\. Total number of implemented observational studies and RCTs (stratified by domain: prevention, diagnosis and treatment).
Time frame: 4 years
Proportion of sites recruiting for an study implemented through the network
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.
Time frame: 4 years
Proportion of patients enrolled through POS-VAP that are part of a preventive study implemented through the network
Proportion (%) of POS-VAP enrolled population included in an embedded preventive study, stratified by observational and interventional embedded studies.
Time frame: 4 years
Proportion of patients enrolled through POS-VAP that are part of a diagnostic study implemented through the network
Proportion (%) of POS-VAP enrolled population included in an embedded diagnostic study, stratified by observational and interventional embedded studies.
Time frame: 4 years
Proportion of VAP patients enrolled through POS-VAP that are part of a treatment study implemented through the network
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.
Time frame: 4 years
Incidence of VAP per 1000 ventilation days
Incidence of VAP per 1000 ventilation days, measured among the Enrolled population, overal and per site
Time frame: 4 years
ICU mortality rate in non-VAP patients
ICU mortality, measured among the Enrolled population not developping VAP, overal and per site
Time frame: 4 years
Time from intubation until VAP diagnosis (days)
Time from start of invasive mechanical ventilation (IMV) until VAP diagnosis (days), measured among the VAP population, overall and per site
Time frame: 4 years
Time under IMV after VAP diagnosis (days)
Time under IMV after VAP diagnosis (days), measured among the VAP population, measured overall and per site
Time frame: 4 years
IMV-free days from VAP diagnosis till day 28 after VAP diagnosis (days)
IMV-free days from VAP diagnosis till day 28 after VAP diagnosis (days), measured among the VAP population, overall and per site
Time frame: 4 years
Length of ICU stay after VAP diagnosis (days)
Length of ICU stay after VAP diagnosis (days), measured among the VAP population, overall and per site
Time frame: 4 years
All-cause mortality at day 28 after VAP diagnosis (%)
All-cause mortality at day 28 after VAP diagnosis (%), measured among the VAP population, overall and per site
Time frame: 4 years
ICU mortality rate
Mortality rate at ICU discharge, measured among the VAP population, overall and per site
Time frame: 4 years
Resolution of signs and symptoms of VAP between days 7 and 10 from VAP diagnosis (%)
Resolution of signs and symptoms of VAP between days 7 and 10 from VAP diagnosis (%), measured among the VAP population, overall and per site
Time frame: 4 years
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Undecided — 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.
Started Aug 2022 (actual). Primary completion is estimated for Dec 2026, 51 months after the start.
Of 63 non-industry observational studies under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's planned 51 months is above that.
Counting every sponsor, half of 63 studies reached it within 20 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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Pneumonia, Ventilator-Associated →
European Clinical Research Alliance for Infectious Diseases (ECRAID)