Perpetual Observational Study - Ventilator Associated Pneumonia

NCT05719259 | Recruiting

• 1 other identifier: ECRAID-Base POS-VAP
• Study Type: observational
• Target: 20,000
• Locations: 13 countries
• Sites: 35

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.

Conditions

Ventilator Associated Pneumonia

Keywords

Ventilator Associated Pneumonia; Hospital Acquired Infection; Mechanical Ventilation; Intensive Care Unit

Outcome Measures

Primary Outcomes (3)

• 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

  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).

  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).

  4 years

Secondary Outcomes (4)

• Proportion of sites recruiting for an study implemented through the network

  4 years

• Proportion of patients enrolled through POS-VAP that are part of a preventive study implemented through the network

  4 years

• Proportion of patients enrolled through POS-VAP that are part of a diagnostic study implemented through the network

  4 years

• Proportion of VAP patients enrolled through POS-VAP that are part of a treatment study implemented through the network

  4 years

Other Outcomes (9)

• Incidence of VAP per 1000 ventilation days

  4 years

• ICU mortality rate in non-VAP patients

  4 years

• Time from intubation until VAP diagnosis (days)

  4 years

Study Arms (3)

Enrolled population

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

VAP population

Subset of the enrolled population fulfilling U.S. Food and Drug Administration (FDA) criteria for VAP diagnosis at any time during the follow up

Microbiologically evaluable VAP population

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Clinical Research Alliance for Infectious Diseases (ECRAID): lead
• Centre Hospitalier Universitaire Dupuytren de Limoges (CHUL): collaborator
• Université de Genève (UNIGE): collaborator
• University Medical Center Utrecht (UMCU): collaborator

Study Sites (35)

University Hospital of Trauma

Tirana, Albania

RECRUITING

Cliniques Universitaires Saint-Luc UCL

Brussels, 1200, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

Hôpital de Jolimont

La Louvière, 7100, Belgium

RECRUITING

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

NOT YET RECRUITING

Clinique Saint Pierre Ottignies

Ottignies-Louvain-la-Neuve, 1340, Belgium

ACTIVE NOT RECRUITING

Clinical Hospital Center Rijeka

Rijeka, Croatia

RECRUITING

General Hospital "Dr. Josip Benčević" Slavonski Brod

Slavonski Brod, Croatia

RECRUITING

University Hospital for Infectious Diseases

Zagreb, Croatia

NOT YET RECRUITING

University Hospital Kralovske Vinohrady

Brno-Vinohrady, Czechia

RECRUITING

University Hospital Motol

Prague, Czechia

RECRUITING

Centre Hospitalier William Morey

Chalon-sur-Saône, 71100, France

RECRUITING

Centre Hospitalier Universitaire Dijon Bourgogne

Dijon, 21079, France

RECRUITING

Centre Hospitalier de Le Mans

Le Mans, 72000, France

RECRUITING

Centre Hospitalier Régional Universitaire de Lille

Lille, 59035, France

RECRUITING

Centre Hospitalier Universitaire Dupuytren of Limoges

Limoges, 87000, France

RECRUITING

Centre Hospitalier Universitaire de Tours

Tours, 37000, France

RECRUITING

University Hospital Leipzig

Leipzig, 04103, Germany

NOT YET RECRUITING

University Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

NOT YET RECRUITING

Evangelismos General Hospital of Athens

Athens, 10676, Greece

NOT YET RECRUITING

Sotiria Thoracic Diseases Hospital of Athens

Athens, 11527, Greece

NOT YET RECRUITING

General University Hospital of Larissa

Larissa, 41334, Greece

NOT YET RECRUITING

IRCCS Ospedale Policlinico Gemelli

Roma, Italy

NOT YET RECRUITING

Deventer Ziekenhuis

Deventer, 7416, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, 3584, Netherlands

RECRUITING

Central Military Emergency University Hospital Dr. Carol Davila

Bucharest, Romania

RECRUITING

Elias University Emergency Hospital

Bucharest, Romania

RECRUITING

University Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, Cordoba, 14004, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

IMED Valencia

Burjassot, Valencia, 46100, Spain

RECRUITING

Vall d'Hebrón University Hospital

Barcelona, 08035, Spain

ACTIVE NOT RECRUITING

John V Farman Intensive Care Unit

Cambridge, United Kingdom

NOT YET RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, EH164SA, United Kingdom

NOT YET RECRUITING

Royal Victoria Infirmary

Newcastle, NE14LP, United Kingdom

NOT YET RECRUITING

Related Publications (1)

• Hassoun-Kheir N, van Werkhoven CH, Dunning J, Jaenisch T, van Beek J, Bielicki J, Butler CC, Francois B, Harbarth S, Hernandez Padilla AC, Horby P, Koopmans M, Lee J, Rodriguez-Bano J, Tacconelli E, Themistocleous Y, van der Velden AW, Bonten M, Goossens H, de Kraker MEA; ECRAID-Base consortium. Perpetual observational studies: new strategies to support efficient implementation of observational studies and randomized trials in infectious diseases. Clin Microbiol Infect. 2022 Dec;28(12):1528-1532. doi: 10.1016/j.cmi.2022.07.024. Epub 2022 Aug 5. No abstract available.

  PMID: 35940566 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Cross Infection

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bruno FRANCOIS, MD

CONTACT

+33 05 55 05 69 83; bruno.francois@chu-limoges.fr

Ana HERNANDEZ, MD, PhD

CONTACT

+33 07 65 15 04 00; ana.hernandez@chu-limoges.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: February 8, 2023
• Study Start: August 3, 2022
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

RO (2); ES (4); AL (1); CZ (2); GB (3); IT (1); NL (2); BE (5); GR (4); DE (1); SE (1); CR (3); FR (6)