Perpetual Observational Study - Ventilator Associated Pneumonia

Ventilator Associated Pneumonia Clinical Trial

— POS-VAP  

Official title:

POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719259
• Other study ID #: ECRAID-Base POS-VAP
• Status: Recruiting
• Start date: August 3, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: April 2024
• Source: European Clinical Research Alliance for Infectious Diseases (ECRAID)
• Contact: Bruno FRANCOIS, MD
• Phone: +33 05 55 05 69 83
• Email: bruno.francois[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: March 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Locations

Country	Name	City	State
Albania	University Hospital of Trauma	Tirana
Belgium	Cliniques Universitaires Saint-Luc UCL	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Hôpital de Jolimont	La Louvière
Belgium	Centre Hospitalier Universitaire de Liège	Liège
Belgium	Clinique Saint Pierre Ottignies	Ottignies-Louvain-la-Neuve
Croatia	Clinical Hospital Center Rijeka	Rijeka
Croatia	General Hospital "Dr. Josip Bencevic" Slavonski Brod	Slavonski Brod
Croatia	University Hospital for Infectious Diseases	Zagreb
Czechia	University Hospital Motol	Praha
Czechia	University Hospital Kralovske Vinohrady	Vinohrady
France	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
Germany	University Hospital Leipzig	Leipzig
Greece	University Hospital of Alexandroupolis	Alexandroupolis
Greece	Evangelismos General Hospital of Athens	Athens
Greece	Sotiria Thoracic Diseases Hospital of Athens	Athens
Greece	General University Hospital of Larissa	Larissa
Italy	IRCCS Ospedale Policlinico Gemelli	Roma
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	University Medical Center Utrecht	Utrecht
Romania	Central Military Emergency University Hospital Dr. Carol Davila	Bucharest
Romania	Elias University Emergency Hospital	Bucharest
Serbia	University Clinical Center of Serbia	Belgrade
Spain	Vall d'Hebrón University Hospital	Barcelona
Spain	IMED Valencia	Burjassot	Valencia
Spain	Hospital Universitario Reina Sofia	Córdoba	Cordoba
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
United Kingdom	John V Farman Intensive Care Unit	Cambridge
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Royal Victoria Infirmary	Newcastle

Sponsors (4)

Lead Sponsor	Collaborator
European Clinical Research Alliance for Infectious Diseases (ECRAID)	Centre Hospitalier Universitaire Dupuytren de Limoges (CHUL), Université de Genève (UNIGE), University Medical Center Utrecht (UMCU)

Countries where clinical trial is conducted

Albania,  Belgium,  Croatia,  Czechia,  France,  Germany,  Greece,  Italy,  Netherlands,  Romania,  Serbia,  Spain,  United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of VAP per 1000 ventilation days	Incidence of VAP per 1000 ventilation days, measured among the Enrolled population, overal and per site	4 years
Other	ICU mortality rate in non-VAP patients	ICU mortality, measured among the Enrolled population not developping VAP, overal and per site	4 years
Other	Time from intubation until VAP diagnosis (days)	Time from start of invasive mechanical ventilation (IMV) until VAP diagnosis (days), measured among the VAP population, overall and per site	4 years
Other	Time under IMV after VAP diagnosis (days)	Time under IMV after VAP diagnosis (days), measured among the VAP population, measured overall and per site	4 years
Other	IMV-free days from VAP diagnosis till day 28 after VAP diagnosis (days)	IMV-free days from VAP diagnosis till day 28 after VAP diagnosis (days), measured among the VAP population, overall and per site	4 years
Other	Length of ICU stay after VAP diagnosis (days)	Length of ICU stay after VAP diagnosis (days), measured among the VAP population, overall and per site	4 years
Other	All-cause mortality at day 28 after VAP diagnosis (%)	All-cause mortality at day 28 after VAP diagnosis (%), measured among the VAP population, overall and per site	4 years
Other	ICU mortality rate	Mortality rate at ICU discharge, measured among the VAP population, overall and per site	4 years
Other	Resolution of signs and symptoms of VAP between days 7 and 10 from VAP diagnosis (%)	Resolution of signs and symptoms of VAP between days 7 and 10 from VAP diagnosis (%), measured among the VAP population, overall and per site	4 years
Primary	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
Primary	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
Primary	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	Proportion of sites recruiting for an study implemented through the network	Average proportion of sites actively recruiting for at least one embedded study at any time during the study period, overall and stratified by observational and interventional embedded studies.	4 years
Secondary	Proportion of patients enrolled through POS-VAP that are part of a preventive study implemented through the network	Proportion (%) of POS-VAP enrolled population included in an embedded preventive study, stratified by observational and interventional embedded studies.	4 years
Secondary	Proportion of patients enrolled through POS-VAP that are part of a diagnostic study implemented through the network	Proportion (%) of POS-VAP enrolled population included in an embedded diagnostic study, stratified by observational and interventional embedded studies.	4 years
Secondary	Proportion of VAP patients enrolled through POS-VAP that are part of a treatment study implemented through the network	Proportion (%) of POS-VAP VAP population enrolled in at least one embedded treatment study with clinical outcome after VAP as endpoint, stratified by observational and interventional embedded studies.	4 years

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