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.
Age≥18 years
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
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.
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
Cohort
Prospective
Not listed
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
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).
Number of studies implemented through the network
3\. Total number of implemented observational studies and RCTs (stratified by domain: prevention, diagnosis and treatment).
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.
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.
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.
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.
Incidence of VAP per 1000 ventilation days
Incidence of VAP per 1000 ventilation days, measured among the Enrolled population, overal and per site
ICU mortality rate in non-VAP patients
ICU mortality, measured among the Enrolled population not developping VAP, overal and per site
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 under IMV after VAP diagnosis (days)
Time under IMV after VAP diagnosis (days), measured among the VAP population, measured overall and per site
Click on the lead sponsor to view all of their trials.
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Lead sponsor
University of Geneva, Switzerland
Collaborator
University Hospital, Limoges
Collaborator
UMC Utrecht
Collaborator