Clinical trial NCT05719259: Perpetual Observational Study - Ventilator Associated Pneumonia
Official title: POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventilator Associated Pneumonia
Keywords: Ventilator Associated Pneumonia
Hospital Acquired Infection
Mechanical Ventilation
Intensive Care Unit
Lead sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID)
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dupuytren de Limoges (CHUL)
name: Université de Genève (UNIGE)
name: University Medical Center Utrecht (UMCU)
First posted: 2023-02-08
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion criteria:

* 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

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.

Primary outcomes:
measure: Number of research sites recruiting patients
timeFrame: 4 years
measure: Number of patients recruited in the study
timeFrame: 4 years
measure: Number of studies implemented through the network
timeFrame: 4 years
Secondary outcomes:
measure: Proportion of sites recruiting for an study implemented through the network
timeFrame: 4 years
measure: Proportion of patients enrolled through POS-VAP that are part of a preventive study implemented through the network
timeFrame: 4 years
measure: Proportion of patients enrolled through POS-VAP that are part of a diagnostic study implemented through the network
timeFrame: 4 years
measure: Proportion of VAP patients enrolled through POS-VAP that are part of a treatment study implemented through the network
timeFrame: 4 years
Other outcomes:
measure: Incidence of VAP per 1000 ventilation days
timeFrame: 4 years
measure: ICU mortality rate in non-VAP patients
timeFrame: 4 years
measure: Time from intubation until VAP diagnosis (days)
timeFrame: 4 years
measure: Time under IMV after VAP diagnosis (days)
timeFrame: 4 years
measure: IMV-free days from VAP diagnosis till day 28 after VAP diagnosis (days)
timeFrame: 4 years
measure: Length of ICU stay after VAP diagnosis (days)
timeFrame: 4 years
measure: All-cause mortality at day 28 after VAP diagnosis (%)
timeFrame: 4 years
measure: ICU mortality rate
timeFrame: 4 years
measure: Resolution of signs and symptoms of VAP between days 7 and 10 from VAP diagnosis (%)
timeFrame: 4 years
Locations:
city: Tirana
country: Albania
facility: University Hospital of Trauma
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc UCL
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: La Louvière
country: Belgium
facility: Hôpital de Jolimont
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Ottignies-Louvain-la-Neuve
country: Belgium
facility: Clinique Saint Pierre Ottignies
city: Rijeka
country: Croatia
facility: Clinical Hospital Center Rijeka
city: Slavonski Brod
country: Croatia
facility: General Hospital "Dr. Josip Benčević" Slavonski Brod
city: Zagreb
country: Croatia
facility: University Hospital for Infectious Diseases
city: Praha
country: Czechia
facility: University Hospital Motol
city: Vinohrady
country: Czechia
facility: University Hospital Kralovske Vinohrady
city: Chalon Sur Saône
country: France
facility: Centre Hospitalier William Morey
city: Dijon
country: France
facility: Centre Hospitalier Universitaire Dijon Bourgogne
city: Le Mans
country: France
facility: Centre Hospitalier de Le Mans
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Limoges
country: France
facility: Centre Hospitalier Universitaire Dupuytren of Limoges
city: Tours
country: France
facility: Centre Hospitalier Universitaire de Tours
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
city: Athens
country: Greece
facility: Sotiria Thoracic Diseases Hospital of Athens
city: Larissa
country: Greece
facility: General University Hospital of Larissa
city: Roma
country: Italy
facility: IRCCS Ospedale Policlinico Gemelli
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Bucharest
country: Romania
facility: Central Military Emergency University Hospital Dr. Carol Davila
city: Bucharest
country: Romania
facility: Elias University Emergency Hospital
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Cordoba
city: Burjassot
country: Spain
facility: IMED Valencia
state: Valencia
city: Barcelona
country: Spain
facility: Vall d'Hebrón University Hospital
city: Cambridge
country: United Kingdom
facility: John V Farman Intensive Care Unit
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
References:
citation: 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.