Skip to main content
OpenTrials
Completed

NCT Number: NCT05293418

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Asymptomatic Diseases Asymptomatic Infections Bacterial Infections Bacterial Infections and Mycoses Colonization, Asymptomatic Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

Milan, MI, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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

Primary outcomes

  1. Incidence of MDRO colonization

    Time frame: 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 outcomes

  1. Incidence of bacterial infections

    Time frame: 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.

  2. risk factors for MDRO colonization and bacterial infections

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study 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

Acronym: MDR_in_Fiera

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 24, 2022
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.