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

NCT05293418 | Completed

• 1 other identifier: 701_2021
• Study Type: observational
• Target: 435
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Bacterial Infections; Colonization, Asymptomatic

Keywords

COVID-19; mechanical ventilation; multidrug resistance; MDR colonization

Outcome Measures

Primary Outcomes (1)

• Incidence of MDRO colonization

  Crude incidence rate of MDRO colonization will be calculated globally and subdivided by hospital of provenance, module of hospitalization and microbiological criteria.

  1000 patient days

Secondary Outcomes (2)

• Incidence of bacterial infections

  1000 patient days

• risk factors for MDRO colonization and bacterial infections

  1000 patient days

Study Arms (1)

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

Interventions

data collection OTHER

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

ICU mechanically ventilated COVID-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated COVID-19 patients admitted to Milano Fiera ICU from October 2020 through May 2021

You may qualify if:

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

You may not qualify if:

• Age \< 18 years
• ICU stay \< 48 hours

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

Milan, MI, 20122, Italy

Location

Related Publications (12)

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

• Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. 2020 Apr 28;323(16):1545-1546. doi: 10.1001/jama.2020.4031. No abstract available.

  PMID: 32167538 BACKGROUND

• Onder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA. 2020 May 12;323(18):1775-1776. doi: 10.1001/jama.2020.4683. No abstract available.

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  PMID: 32105632 BACKGROUND

• Grasselli G, Scaravilli V, Mangioni D, Scudeller L, Alagna L, Bartoletti M, Bellani G, Biagioni E, Bonfanti P, Bottino N, Coloretti I, Cutuli SL, De Pascale G, Ferlicca D, Fior G, Forastieri A, Franzetti M, Greco M, Guzzardella A, Linguadoca S, Meschiari M, Messina A, Monti G, Morelli P, Muscatello A, Redaelli S, Stefanini F, Tonetti T, Antonelli M, Cecconi M, Foti G, Fumagalli R, Girardis M, Ranieri M, Viale P, Raviglione M, Pesenti A, Gori A, Bandera A. Hospital-Acquired Infections in Critically Ill Patients With COVID-19. Chest. 2021 Aug;160(2):454-465. doi: 10.1016/j.chest.2021.04.002. Epub 2021 Apr 20.

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• Rouze A, Martin-Loeches I, Povoa P, Makris D, Artigas A, Bouchereau M, Lambiotte F, Metzelard M, Cuchet P, Boulle Geronimi C, Labruyere M, Tamion F, Nyunga M, Luyt CE, Labreuche J, Pouly O, Bardin J, Saade A, Asfar P, Baudel JL, Beurton A, Garot D, Ioannidou I, Kreitmann L, Llitjos JF, Magira E, Megarbane B, Meguerditchian D, Moglia E, Mekontso-Dessap A, Reignier J, Turpin M, Pierre A, Plantefeve G, Vinsonneau C, Floch PE, Weiss N, Ceccato A, Torres A, Duhamel A, Nseir S; coVAPid study Group. Relationship between SARS-CoV-2 infection and the incidence of ventilator-associated lower respiratory tract infections: a European multicenter cohort study. Intensive Care Med. 2021 Feb;47(2):188-198. doi: 10.1007/s00134-020-06323-9. Epub 2021 Jan 3.

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• Bogossian EG, Taccone FS, Izzi A, Yin N, Garufi A, Hublet S, Njimi H, Ego A, Gorham J, Byl B, Brasseur A, Hites M, Vincent JL, Creteur J, Grimaldi D. The Acquisition of Multidrug-Resistant Bacteria in Patients Admitted to COVID-19 Intensive Care Units: A Monocentric Retrospective Case Control Study. Microorganisms. 2020 Nov 19;8(11):1821. doi: 10.3390/microorganisms8111821.

  PMID: 33227956 BACKGROUND

• Baiou A, Elbuzidi AA, Bakdach D, Zaqout A, Alarbi KM, Bintaher AA, Ali MMB, Elarabi AM, Ali GAM, Daghfal J, Almaslamani MA, Ibrahim ASS, Alkhal A, Omrani AS. Clinical characteristics and risk factors for the isolation of multi-drug-resistant Gram-negative bacteria from critically ill patients with COVID-19. J Hosp Infect. 2021 Apr;110:165-171. doi: 10.1016/j.jhin.2021.01.027. Epub 2021 Feb 6.

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  PMID: 33565961 BACKGROUND

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MeSH Terms

Conditions

COVID-19; Bacterial Infections; Asymptomatic Infections

Interventions

Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 24, 2022
• Study Start: October 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: September 30, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

IT (1)