InfectionsNCT05972980
Ventilator-Associated Pneumonia in Critically Ill COVID-19 vs. Non-COVID-19 Patients
An observational study of Infections and Critical Illness, run by University of Turin, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Critical Illness, Superinfection
- What is being tested?
- COVID-19
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2016to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients diagnosed with ventilator-acquired pneumonia admitted to the intensive care unit of the primary hospital "Molinette," Città della Salute e della Scienza, Turin, Italy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ventilator-Associated Pneumonia and Multidrug-Resistant Pathogens: A Prospective Observational Monocentric Comparative Study Between Critically Ill Non-COVID-19 and COVID-19 Patients
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).
Read the 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.
- Conditions
- Infections, Critical Illness, Superinfection, Organ Failure, Multiple, Ventilator Associated Pneumonia, Septic Shock
- Being tested
- COVID-19
- Medical subject headings
- Infections, Critical Illness, Superinfection, Multiple Organ Failure, Pneumonia, Ventilator-Associated, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-COVID-19 cohort | Patients with Ventilator Acquired Pneumonia without COVID-19. The patients belonging to the NON-COVID cohort were admitted to three intensive care units at Molinette Hospital (Turin, Italy): * General Intensive Care Unit - admitting primarily medically critical patients and a smaller proportion of surgical patients, originating from the Hospital's Emergency Department or other Intensive Care Units in Piedmont. It serves as the regional referral center for Extracorporeal Membrane Oxygenation (ECMO). * Emergency Department - Intensive Care Unit (PSAR) - admitting both medical and surgical patients in urgent conditions. * Cardiac - Intensive Care Unit- admitting patients undergoing elective or emergency cardio-surgical interventions, and serving as a referral center for heart and lung transplants and the implantation of external ventricular assists. | |
| COVID-19 cohort | Patients with Ventilator Acquired Pneumonia with COVID-19. Confirmation of pneumonia was achieved by using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique on a sample collected from the lower respiratory tract.
The COVID-19 cohort consists of patients admitted at the "Città della Salute e della Scienza" University Hospital (Turin, Italy) in two intensive care units at Molinette Hospital, dedicated to treating critically ill patients with COVID-19. Receives: Other: COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality within the first 28 days from ICU admission
Measured: 28 days
Secondary outcomes (9)
ICU mortality
Mortality during intensive care unit stay
Measured: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Hospital mortality
Mortality during hospital stay
Measured: From date of enrollment until the date of hospital discharge, assessed up to 6 months
Mechanical ventilation days
Days of mechanical ventilation length of stay
Measured: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Ventilator acquired pneumonia incidence
Incidence of ventilator acquired pneumonia
Measured: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Ventilator acquired pneumonia incidence
Incidence of ventilator acquired pneumonia
Measured: 28 days
Multidrug-resistant micro-organisms incidence
Incidence of Multidrug-resistant micro-organisms
Measured: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Difficult to treat pathogens incidence
Incidence of difficult to treat pathogens
Measured: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Hospital length of stay
Duration of hospital length of stay
Measured: From date of enrollment until the date of hospital discharge, assessed up to 6 months
Intensive care unit length of stay
Duration of intensive care unit length of stay
Measured: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Jan 2016
- Primary completion1 Jan 2016
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Brazzi, Study chair, University of Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972980
- Sponsor's protocol ID
- MR-VAP-C19
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator-Associated Pneumonia and Multidrug-Resistant Pathogens: A Prospective Observational Monocentric Comparative Study Between Critically Ill Non-COVID-19 and COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05972980
- Acronym / sponsor ID
- MR-VAP-C19
- Conditions
- Infections, Critical Illness, Superinfection, Organ Failure, Multiple, Ventilator Associated Pneumonia, Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-COVID-19 cohort | – | –Patients with Ventilator Acquired Pneumonia without COVID-19. The patients belonging to the NON-COVID cohort were admitted to three intensive care units at Molinette Hospital (Turin, Italy): * General Intensive Care Unit - admitting primarily medically critical patients and a smaller proportion of surgical patients, originating from the Hospital's Emergency Department or other Intensive Care Units in Piedmont. It serves as the regional referral center for Extracorporeal Membrane Oxygenation (ECMO). * Emergency Department - Intensive Care Unit (PSAR) - admitting both medical and surgical patients in urgent conditions. * Cardiac - Intensive Care Unit- admitting patients undergoing elective or emergency cardio-surgical interventions, and serving as a referral center for heart and lung transplants and the implantation of external ventricular assists. |
| COVID-19 cohort | – | Other: COVID-19Patients with Ventilator Acquired Pneumonia with COVID-19. Confirmation of pneumonia was achieved by using the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique on a sample collected from the lower respiratory tract. The COVID-19 cohort consists of patients admitted at the "Città della Salute e della Scienza" University Hospital (Turin, Italy) in two intensive care units at Molinette Hospital, dedicated to treating critically ill patients with COVID-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients diagnosed with ventilator-acquired pneumonia admitted to the intensive care unit of the primary hospital "Molinette," Città della Salute e della Scienza, Turin, Italy.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19The 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. | Other | COVID-19 cohort |
Primary outcome
Mortality
Time frame: 28 days
Mortality within the first 28 days from ICU admission
9 secondary outcomes
ICU mortality
Time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Hospital mortality
Time frame: From date of enrollment until the date of hospital discharge, assessed up to 6 months
Mechanical ventilation days
Time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Ventilator acquired pneumonia incidence
Time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Ventilator acquired pneumonia incidence
Time frame: 28 days
Multidrug-resistant micro-organisms incidence
Time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Difficult to treat pathogens incidence
Time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Hospital length of stay
Time frame: From date of enrollment until the date of hospital discharge, assessed up to 6 months
Intensive care unit length of stay
Time frame: From date of enrollment until the date of intensive care unit discharge, assessed up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Brazzi study chair
University of Torino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections and Critical Illness, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.