Observational study on Ventilator Associated Pneumonia in ICUs
POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia
This study is trying to set up a network of ICUs to help find better ways to prevent and treat Ventilator Associated Pneumonia in patients on mechanical ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Clinical Research Alliance for Infectious Diseases (ECRAID) Academic / other |
| Locations | 35 sites (Tirana and 34 other locations) |
| Trial ID | NCT05719259 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on Ventilator Associated Pneumonia (VAP), a serious bacterial infection affecting patients in Intensive Care Units (ICUs) who require mechanical ventilation. The study aims to establish and continuously train a network of ICUs to facilitate future clinical trials evaluating preventive and therapeutic options for VAP. By creating a structured network, the study seeks to improve the efficiency and quality of research in this area, ultimately preparing sites for randomized controlled trials. The initiative will also implement informed consent processes and maintain ongoing observational studies to gather valuable data.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older who are at risk of acquiring VAP during their ICU stay and are expected to be on mechanical ventilation for more than 48 hours.
Not a fit: Patients who are imminently dying or for whom full active treatment is not being pursued will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and treatment strategies for Ventilator Associated Pneumonia, reducing morbidity and mortality in ICU patients.
How similar studies have performed: While this approach is novel in its focus on creating a dedicated network for VAP research, similar observational studies have shown promise in enhancing the execution of clinical trials in other areas.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tirana and 34 other locations
- University Hospital of Trauma — Tirana, Albania (Recruiting)
- Cliniques Universitaires Saint-Luc UCL — Bruxelles, Belgium (Recruiting)
- Universitair Ziekenhuis Gent — Gent, Belgium (Recruiting)
- Hôpital de Jolimont — La Louvière, Belgium (Recruiting)
- Centre Hospitalier Universitaire de Liège — Liège, Belgium (Not_yet_recruiting)
- Clinique Saint Pierre Ottignies — Ottignies-Louvain-la-Neuve, 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 Motol — Praha, Czechia (Recruiting)
- University Hospital Kralovske Vinohrady — Vinohrady, Czechia (Recruiting)
- Centre Hospitalier William Morey — Chalon Sur Saône, France (Recruiting)
- Centre Hospitalier Universitaire Dijon Bourgogne — Dijon, France (Recruiting)
- Centre Hospitalier de Le Mans — Le Mans, France (Recruiting)
- Centre Hospitalier Régional Universitaire de Lille — Lille, France (Recruiting)
- Centre Hospitalier Universitaire Dupuytren of Limoges — Limoges, France (Recruiting)
- Centre Hospitalier Universitaire de Tours — Tours, France (Recruiting)
- University Hospital Leipzig — Leipzig, Germany (Not_yet_recruiting)
- University Hospital of Alexandroupolis — Alexandroupolis, Greece (Not_yet_recruiting)
- Evangelismos General Hospital of Athens — Athens, Greece (Not_yet_recruiting)
- Sotiria Thoracic Diseases Hospital of Athens — Athens, Greece (Not_yet_recruiting)
- General University Hospital of Larissa — Larissa, Greece (Not_yet_recruiting)
- IRCCS Ospedale Policlinico Gemelli — Roma, Italy (Not_yet_recruiting)
- Deventer Ziekenhuis — Deventer, Netherlands (Recruiting)
- University Medical Center Utrecht — Utrecht, 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, Serbia (Recruiting)
- Hospital Universitario Central de Asturias — Oviedo, Asturias, Spain (Recruiting)
- Hospital Universitario Reina Sofia — Córdoba, Cordoba, Spain (Recruiting)
- IMED Valencia — Burjassot, Valencia, Spain (Recruiting)
- Vall d'Hebrón University Hospital — Barcelona, Spain (Active_not_recruiting)
- John V Farman Intensive Care Unit — Cambridge, United Kingdom (Not_yet_recruiting)
- Royal Infirmary of Edinburgh — Edinburgh, United Kingdom (Not_yet_recruiting)
- Royal Victoria Infirmary — Newcastle, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Bruno FRANCOIS, MD
- Email: bruno.francois@chu-limoges.fr
- Phone: +33 05 55 05 69 83
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.