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Ventilator-Associated Pneumonia in Critically Ill COVID-19 vs. Non-COVID-19 Patients

Ventilator-Associated Pneumonia and Multidrug-Resistant Pathogens: A Prospective Observational Monocentric Comparative Study Between Critically Ill Non-COVID-19 and COVID-19 Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05972980
Enrollment
200
Registered
2023-08-02
Start date
2016-01-01
Completion date
2022-12-31
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Infections, Organ Failure, Multiple, Septic Shock, Superinfection, Ventilator Associated Pneumonia

Brief summary

The COVID-19 pandemic has led to an increased incidence of ventilator-associated pneumonia (VAP) among critically ill patients. However, in a context of high prevalence of multidrug-resistant organisms (MDROs) there is a lack of direct comparison between the incidence of VAP in COVID-19 and non-COVID-19 cohorts. The investigators conducted a prospective, single-center cohort study comparing COVID-19 patients admitted to the intensive care unit (ICU) of the Città della Salute e della Scienza University Hospital in Turin, Italy, between March 2020 and December 2021 (COVID-19 group), with a historical cohort of ICU-mixed patients admitted between June 2016 and March 2018 (NON-COVID-19 group).

Detailed description

The study aims to explore the occurrence and characteristics of ventilator-associated pneumonia (VAP) in critically ill patients during two distinct periods: the pre-pandemic era and the COVID-19 pandemic. VAP, a serious complication arising from invasive mechanical ventilation (IMV) lasting at least 48 hours, had a crude incidence of 5% to 40% before the COVID-19 pandemic, whereas COVID-19 patients experienced even higher rates, reaching 48-64%. The COVID-19 pandemic triggered an unprecedented rise in ICU admissions due to severe acute respiratory syndrome caused by the SARS-CoV-2 virus, leading to a considerable number of patients requiring IMV. Mechanical ventilation is a known risk factor for VAP, and COVID-19 exacerbates this risk due to factors like disease-induced immunoparalysis, prolonged mechanical ventilation and sedation, and more frequent application of prone positioning. Despite the widespread need for prolonged mechanical ventilation in COVID-19 patients, few studies have compared the impact of VAP between pre-pandemic and COVID-19 populations. Additionally, limited research exists on the risk factors for VAP development in COVID-19 patients and the use of scoring systems like SAPS and SOFA as prognostic factors in this specific context. Although the coVAPid study offered insights into VAP risk factors in COVID-19 patients compared to those with influenza, it inadequately addressed the prevalence of multidrug-resistant organisms (MDROs) in this population, particularly carbapenem-resistant Acinetobacter baumannii (CR-Ab). Hence, this study aims to bridge this knowledge gap by investigating VAP's impact in a setting characterized by a high incidence of multidrug resistance. To achieve this, the study will take place at the Molinette Hospital of the Città della Salute e della Scienza University Hospital in Turin, Italy, over a six-year period, spanning from January 2016 to December 2022. This retrospective, observational, and monocentric study will focus on two distinct cohorts: the pre-pandemic cohort (NON-COVID-19) and the COVID-19 cohort. Researchers will identify ventilator-associated pneumonia (VAP) episodes based on the current definitions provided by the European Center for Disease Prevention and Control (ECDC). Patients will be monitored until hospital discharge to assess outcomes, including ICU mortality, overall mortality, duration of ICU stay, and duration of hospitalization.

Interventions

OTHERCOVID-19

The investigators stratified our population based on COVID-19 virus positivity to identify any risk factors in this population compared to the NON-COVID-19 population.

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All adult patients diagnosed with ventilator-associated pneumonia * Patients admitted to the intensive care units * Patients who underwent mechanical ventilation for a duration longer than 48 hours

Exclusion criteria

* Patients in extreme end-of-life conditions * Pregnant individuals * Patients under 18 years of age * Patients who did not meet the diagnosis criteria for ventilator-associated pneumonia * Patients who underwent mechanical ventilation for a duration equal to or shorter than 48 hours * Ventilator-associated tracheobronchitis

Design outcomes

Primary

MeasureTime frameDescription
Mortality28 daysMortality within the first 28 days from ICU admission

Secondary

MeasureTime frameDescription
Hospital mortalityFrom date of enrollment until the date of hospital discharge, assessed up to 6 monthsMortality during hospital stay
Mechanical ventilation daysFrom date of enrollment until the date of intensive care unit discharge, assessed up to 6 monthsDays of mechanical ventilation length of stay
Ventilator acquired pneumonia incidenceFrom date of enrollment until the date of intensive care unit discharge, assessed up to 6 monthsIncidence of ventilator acquired pneumonia
ICU mortalityFrom date of enrollment until the date of intensive care unit discharge, assessed up to 6 monthsMortality during intensive care unit stay
Difficult to treat pathogens incidenceFrom date of enrollment until the date of intensive care unit discharge, assessed up to 6 monthsIncidence of difficult to treat pathogens
Hospital length of stayFrom date of enrollment until the date of hospital discharge, assessed up to 6 monthsDuration of hospital length of stay
Intensive care unit length of stayFrom date of enrollment until the date of intensive care unit discharge, assessed up to 6 monthsDuration of intensive care unit length of stay
Multidrug-resistant micro-organisms incidenceFrom date of enrollment until the date of intensive care unit discharge, assessed up to 6 monthsIncidence of Multidrug-resistant micro-organisms

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026