Perpetual Observational Study - Ventilator Associated Pneumonia
NCT ID: NCT05719259
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20000 participants
OBSERVATIONAL
2022-08-03
2026-03-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dupuytren de Limoges (CHUL)
UNKNOWN
Université de Genève (UNIGE)
UNKNOWN
University Medical Center Utrecht (UMCU)
UNKNOWN
European Clinical Research Alliance for Infectious Diseases (ECRAID)
OTHER
Responsible Party
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Locations
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University Hospital of Trauma
Tirana, , Albania
Cliniques Universitaires Saint-Luc UCL
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , 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
Prague, , Czechia
University Hospital Kralovske Vinohrady
Vinohrady, , Czechia
Centre Hospitalier William Morey
Chalon-sur-Saône, , France
Centre Hospitalier Universitaire Dijon Bourgogne
Dijon, , France
Centre Hospitalier de Le Mans
Le Mans, , France
Centre Hospitalier Régional Universitaire de Lille
Lille, , France
Centre Hospitalier Universitaire Dupuytren of Limoges
Limoges, , France
Centre Hospitalier Universitaire de Tours
Tours, , France
University Hospital Leipzig
Leipzig, , Germany
University Hospital of Alexandroupolis
Alexandroupoli, , Greece
Evangelismos General Hospital of Athens
Athens, , Greece
Sotiria Thoracic Diseases Hospital of Athens
Athens, , Greece
General University Hospital of Larissa
Larissa, , Greece
IRCCS Ospedale Policlinico Gemelli
Roma, , Italy
Deventer Ziekenhuis
Deventer, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Central Military Emergency University Hospital Dr. Carol Davila
Bucharest, , Romania
Elias University Emergency Hospital
Bucharest, , Romania
University Clinical Center of Serbia
Belgrade, , Serbia
Hospital Universitario Reina Sofia
Córdoba, Cordoba, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
IMED Valencia
Burjassot, Valencia, Spain
Vall d'Hebrón University Hospital
Barcelona, , Spain
John V Farman Intensive Care Unit
Cambridge, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Royal Victoria Infirmary
Newcastle, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Silva LEKA, Dr
Role: primary
Role: backup
Role: backup
References
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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.
Related Links
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Related Info
Other Identifiers
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ECRAID-Base POS-VAP
Identifier Type: -
Identifier Source: org_study_id
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