MDR_in_Fiera: Incidence of Colonization by Multidrug-resistant Organisms in Mechanically Ventilated Patients With Severe COVID-19

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)

Overall Status

Recruiting

CT.gov ID

NCT05293418

Collaborator

(none)

400

Enrollment

Location

Anticipated Duration (Months)

23.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective single-center cohort study to evaluate the incidence of colonization by multidrug-resistant organisms (MDRO) in mechanically ventilated patients admitted to a large intensive care unit (ICU) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the second wave of COVID-19 pandemic (October 2020-May 2021) in Lombardy, Italy. As secondary outcomes, the study evaluates the overall incidence of infections during the ICU stay and assesses the risk factors associated to bacterial superinfection and MDRO colonization.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Bacterial Infections Colonization, Asymptomatic	Other: data collection

Detailed Description

Bacterial superinfection represents a major treat for patients admitted to intensive care unit (ICU), severely impacting clinical outcome and length of hospital stay. Several studies showed that previous multidrug-resistant organisms (MDRO) colonization is a major risk factor for subsequent infection. The coronavirus disease 2019 (COVID-19) pandemic caused an unprecedented rate of ICU admissions and drastically changed the ICU care itself, in terms of infection control measures and therapeutic usage of immunomodulating drugs. Depending on the study, incidence of bacterial infections acquired in COVID-19 ICUs ranges from 12% to 50%. In a retrospective, multicenter study conducted in 8 Italian ICUs during the first wave of the pandemic (March 2020-May 2020), 46% of the patients developed a bacterial superinfection. Notably, 35% of these infections were caused by MDRO. To date there is still scarce evidence on the incidence of colonization by MDRO in patients admitted to COVID-19 ICUs, and little data has been collected on risk factors associated with MDRO colonization. Based on case series analysis, MDRO colonization has been associated with presence of invasive devices, prolonged ICU stay and use of corticosteroids and antibiotics.

The Milano Fiera ICU was a large, modular, COVID-19 ICU built in Milan, Italy, in March 2020 to face the impact of the pandemic. It was composed of distinct units (modules) to accommodate up to 100 patients with severe SARS-CoV-2 infection requiring mechanical ventilation. Since October 2020, over 400 mechanically ventilated COVID-19 patients were admitted to Milano Fiera ICU. Despite each module was managed by staff coming from different hospitals in the Milan area, microbiological surveillance was standardized, and all modules referred to the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan for laboratory analysis and infectious disease specialist consultation.

The present retrospective single-center cohort study aims to evaluate the incidence of colonization by MDRO in patients admitted to the Milano Fiera ICU during the second wave of COVID-19 pandemic (October 2020-May 2021). Furthermore, the study will evaluate the overall incidence of infections during the ICU stay and analyze the risk factors associated with bacterial superinfection and with MDRO colonization.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Retrospective Single-center Cohort Study to Evaluate the Incidence of Colonization by Multidrug-resistant Organisms in Mechanically Ventilated Patients With Severe COVID-19 Admitted to a Large Intensive Care Unit in Milan, Italy

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
ICU mechanically ventilated COVID-19 patients Patients admitted to Milano Fiera ICU for COVID-19 requiring mechanical ventilation from October 2020 through May 2021	Other: data collection data collection from medical records and the microbiological surveillance system of the enrolled patients

Arm

Intervention/Treatment

ICU mechanically ventilated COVID-19 patients

Patients admitted to Milano Fiera ICU for COVID-19 requiring mechanical ventilation from October 2020 through May 2021

Other: data collection

data collection from medical records and the microbiological surveillance system of the enrolled patients

Outcome Measures

Primary Outcome Measures

Incidence of MDRO colonization [1000 patient days]
Crude incidence rate of MDRO colonization will be calculated globally and subdivided by hospital of provenance, module of hospitalization and microbiological criteria.

Secondary Outcome Measures

Incidence of bacterial infections [1000 patient days]
Crude incidence rate of bacterial infections (both MDR and antibiotic-susceptible bacteria) will be calculated globally and subdivided by hospital of provenance, module of hospitalization and microbiological criteria.
risk factors for MDRO colonization and bacterial infections [1000 patient days]
Cumulative incidence rate of MDRO colonization and bacterial infections, obtained from multivariable models that consider the competitive effect of death on colonization (main event). The model will provide for each analyzed predictor (i.e., patient conditions at enrollment, previous exposition to corticosteroid and/or antibiotic therapy, biochemical indexes) the corresponding sub-hazard ratio

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

COVID-19-related respiratory failure
Mechanical ventilation at least 48 hours

Exclusion Criteria:

Age < 18 years
ICU stay < 48 hours

Concurrent participation in other clinical trials is not a criterion for exclusion from this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation	Milan	MI	Italy	20122

Sponsors and Collaborators

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

Principal Investigator: Gianpaola Monti, MD, Intensive Care Unit, ASST Grande Ospedale Metropolitano Niguarda - Milano (Italy)
Principal Investigator: Andrea Gori, MD, Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation - Milano (Italy)