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

COVID-19 Clinical Trial

— MDR_in_Fiera  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05293418
• Other study ID #: 701_2021
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: September 30, 2022
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Infections
• Bacterial Infections
• COVID-19

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (12)

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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. — View Citation

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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. — View Citation

Karruli A, Boccia F, Gagliardi M, Patauner F, Ursi MP, Sommese P, De Rosa R, Murino P, Ruocco G, Corcione A, Andini R, Zampino R, Durante-Mangoni E. Multidrug-Resistant Infections and Outcome of Critically Ill Patients with Coronavirus Disease 2019: A Single Center Experience. Microb Drug Resist. 2021 Sep;27(9):1167-1175. doi: 10.1089/mdr.2020.0489. Epub 2021 Feb 17. — View Citation

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. Erratum In: JAMA. 2020 Apr 28;323(16):1619. — View Citation

Patel A, Emerick M, Cabunoc MK, Williams MH, Preas MA, Schrank G, Rabinowitz R, Luethy P, Johnson JK, Leekha S. Rapid Spread and Control of Multidrug-Resistant Gram-Negative Bacteria in COVID-19 Patient Care Units. Emerg Infect Dis. 2021 Apr;27(4):1234-1237. doi: 10.3201/eid2704.204036. Epub 2021 Feb 10. — View Citation

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. Erratum In: Intensive Care Med. 2022 Apr;48(4):514-515. — View Citation

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* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of bacterial infections	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.	1000 patient days
Secondary	risk factors for MDRO colonization and bacterial infections	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	1000 patient days