POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia

Status: Recruiting
Location: See all (33) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Albania
University Hospital of Trauma
RECRUITING
Tirana
Belgium
Cliniques Universitaires Saint-Luc UCL
RECRUITING
Brussels
Universitair Ziekenhuis Gent
RECRUITING
Ghent
Hôpital de Jolimont
RECRUITING
La Louvière
Centre Hospitalier Universitaire de Liège
NOT_YET_RECRUITING
Liège
Clinique Saint Pierre Ottignies
ACTIVE_NOT_RECRUITING
Ottignies-louvain-la-neuve
Croatia
Clinical Hospital Center Rijeka
RECRUITING
Rijeka
General Hospital Dr. Josip Benčević Slavonski Brod
RECRUITING
Slavonski Brod
University Hospital for Infectious Diseases
NOT_YET_RECRUITING
Zagreb
France
Centre Hospitalier William Morey
RECRUITING
Chalon-sur-saône
Centre Hospitalier Universitaire Dijon Bourgogne
RECRUITING
Dijon
Centre Hospitalier de Le Mans
RECRUITING
Le Mans
Centre Hospitalier Régional Universitaire de Lille
RECRUITING
Lille
Centre Hospitalier Universitaire Dupuytren of Limoges
RECRUITING
Limoges
Centre Hospitalier Universitaire de Tours
RECRUITING
Tours
Germany
University Hospital Leipzig
NOT_YET_RECRUITING
Leipzig
Greece
University Hospital of Alexandroupolis
NOT_YET_RECRUITING
Alexandroupoli
Evangelismos General Hospital of Athens
NOT_YET_RECRUITING
Athens
Sotiria Thoracic Diseases Hospital of Athens
NOT_YET_RECRUITING
Athens
General University Hospital of Larissa
NOT_YET_RECRUITING
Larissa
Italy
IRCCS Ospedale Policlinico Gemelli
NOT_YET_RECRUITING
Roma
Netherlands
Deventer Ziekenhuis
RECRUITING
Deventer
University Medical Center Utrecht
RECRUITING
Utrecht
Romania
Central Military Emergency University Hospital Dr. Carol Davila
RECRUITING
Bucharest
Elias University Emergency Hospital
RECRUITING
Bucharest
Serbia
University Clinical Center of Serbia
RECRUITING
Belgrade
Spain
Vall d'Hebrón University Hospital
ACTIVE_NOT_RECRUITING
Barcelona
IMED Valencia
RECRUITING
Burjassot
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
United Kingdom
John V Farman Intensive Care Unit
NOT_YET_RECRUITING
Cambridge
Royal Infirmary of Edinburgh
NOT_YET_RECRUITING
Edinburgh
Royal Victoria Infirmary
NOT_YET_RECRUITING
Newcastle
Contact Information
Primary
Bruno FRANCOIS, MD
bruno.francois@chu-limoges.fr
+33 05 55 05 69 83
Backup
Ana HERNANDEZ, MD, PhD
ana.hernandez@chu-limoges.fr
+33 07 65 15 04 00
Time Frame
Start Date: 2022-08-03
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 20000
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: University Medical Center Utrecht (UMCU), Université de Genève (UNIGE), Centre Hospitalier Universitaire Dupuytren de Limoges (CHUL)
Leads: European Clinical Research Alliance for Infectious Diseases (ECRAID)

This content was sourced from clinicaltrials.gov