Perpetual Observational Study - Ventilator Associated Pneumonia

Study Overview
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Brief Summary
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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.

Detailed Description
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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 a continuous activity to carry out observational studies in this specific field, implementing informed consent, increasing quality and efficiency, and facilitating contracting.

Official Title
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POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia

Conditions
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Ventilator Associated Pneumonia

Intervention / Treatment
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* Other: VAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > or = 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. 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 relative of the study patient OR. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Specific patient group developing Ventilator Associated Pneumonia in ICU<br>Participants will be followed up to 28 days after VAP onset or until ICU discharge, whichever comes latest. Visit 0: Screening Screening of every eligible subject for inclusion/exclusion criteria, from the moment of initiation of IMV. Visit 1: Enrolment Takes place within the 48h after meeting eligibility criteria. Daily: Screening for the FDA criteria for VAP diagnosis up to the occurrence of VAP or until ICU discharge. | Other: VAP<br>* To continuously evaluate VAP clinical and microbiological epidemiology in European ICUs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective - Total number of sites in the POS-VAP network that actively recruited patients. | To determine the quality and efficiency of a research platform for VAP in ICUs by measuring the timeliness of enrolling eligible patients. | 4 years | 
| Overarching objective 1 | Total number of enrolled patients in the POS-VAP network per analysis population. | 4 years | 
| Overarching objective 2 | Total number of implemented observational studies and RCTs (stratified by domain: prevention, treatment and intervention). | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary objective: | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, VAP