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

NCT ID: NCT05293418

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 435 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-09-30

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.

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.

Conditions

COVID-19; Bacterial Infections; Colonization, Asymptomatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ICU mechanically ventilated COVID-19 patients

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

data collection

Intervention Type: OTHER

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

Interventions

data collection

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianpaola Monti, MD

Role: PRINCIPAL_INVESTIGATOR

Intensive Care Unit, ASST Grande Ospedale Metropolitano Niguarda - Milano (Italy)

Andrea Gori, MD

Role: PRINCIPAL_INVESTIGATOR

Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation - Milano (Italy)

Locations

IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

Milan, MI, Italy

Countries

Italy

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Other Identifiers

701_2021

Identifier Type: -

Identifier Source: org_study_id