Perpetual Observational Study - Ventilator Associated Pneumonia

Recruiting

• Conditions: Ventilator Associated Pneumonia

• Registration Number: NCT05719259
• Lead Sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID)

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-07-06
• Study Start: 2022-08-03
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2025-12-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of research sites recruiting patients	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
Number of patients recruited in the study	4 years	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	4 years	3. Total number of implemented observational studies and RCTs (stratified by domain: prevention, diagnosis and treatment).

Secondary Outcome Measures

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

Trial Locations

Locations (35)

University Hospital of Trauma; 🇦🇱 Tirana, Albania

Cliniques Universitaires Saint-Luc UCL; 🇧🇪 Bruxelles, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Hôpital de Jolimont; 🇧🇪 La Louvière, Belgium

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium

Clinique Saint Pierre Ottignies; 🇧🇪 Ottignies-Louvain-la-Neuve, Belgium

Clinical Hospital Center Rijeka; 🇭🇷 Rijeka, Croatia

General Hospital "Dr. Josip Benčević" Slavonski Brod; 🇭🇷 Slavonski Brod, Croatia

University Hospital for Infectious Diseases; 🇭🇷 Zagreb, Croatia

University Hospital Motol; 🇨🇿 Praha, Czechia

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