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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05972980
Other study ID # MR-VAP-C19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2022

Study information

Verified date July 2023
Source University of Turin, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 31, 2022
Est. primary completion date January 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
COVID-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.

Locations

Country Name City State
Italy AOU Città della Salute e della Scienza di Torino Torino

Sponsors (1)

Lead Sponsor Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Mortality within the first 28 days from ICU admission 28 days
Secondary ICU mortality Mortality during intensive care unit stay From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Secondary Hospital mortality Mortality during hospital stay From date of enrollment until the date of hospital discharge, assessed up to 6 months
Secondary Mechanical ventilation days Days of mechanical ventilation length of stay From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Secondary Ventilator acquired pneumonia incidence Incidence of ventilator acquired pneumonia From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Secondary Ventilator acquired pneumonia incidence Incidence of ventilator acquired pneumonia 28 days
Secondary Multidrug-resistant micro-organisms incidence Incidence of Multidrug-resistant micro-organisms From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Secondary Difficult to treat pathogens incidence Incidence of difficult to treat pathogens From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Secondary Hospital length of stay Duration of hospital length of stay From date of enrollment until the date of hospital discharge, assessed up to 6 months
Secondary Intensive care unit length of stay Duration of intensive care unit length of stay From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
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