COVID-19MDR_in_FieraNCT05293418
Incidence of Colonization by Multidrug-resistant Organisms in Mechanically Ventilated Patients With Severe COVID-19
An observational study of COVID-19 and Bacterial Infections, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Bacterial Infections, Colonization, Asymptomatic
- What is being tested?
- data collection
- How many people
- 435 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated COVID-19 patients admitted to Milano Fiera ICU from October 2020 through May 2021
Who may be able to join
- COVID-19-related respiratory failure
- Mechanical ventilation at least 48 hours
Who cannot join
- Age < 18 years
- ICU stay < 48 hours
- Concurrent participation in other clinical trials is not a criterion for exclusion from this study
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Milan, MI, 20122
About this study
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
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.
Read the 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
- Being tested
- data collection
- Keywords
- COVID-19, mechanical ventilation, multidrug resistance, MDR colonization
- Medical subject headings
- COVID-19, Bacterial Infections, Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
data collection from medical records and the microbiological surveillance system of the enrolled patients
| Study group | Role | What they receive |
|---|---|---|
| ICU mechanically ventilated COVID-19 patients | Patients admitted to Milano Fiera ICU for COVID-19 requiring mechanical ventilation from October 2020 through May 2021 Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1000 patient days
Secondary outcomes (2)
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.
Measured: 1000 patient days
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
Measured: 1000 patient days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Oct 2020
- Primary completion30 May 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianpaola Monti, MD, Principal investigator, Intensive Care Unit, ASST Grande Ospedale Metropolitano Niguarda - Milano (Italy)Andrea Gori, MD, Principal investigator, Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation - Milano (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293418
- Sponsor's protocol ID
- 701_2021
- Acronym
- MDR_in_Fiera
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data will be shared upon written request to the study director
Publications
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.
PubMed 32091533Grasselli 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.
PubMed 32167538Onder 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.
PubMed 32203977Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PubMed 32105632Grasselli 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.
PubMed 33857475Rouze 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.
PubMed 33388794Bogossian 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.
PubMed 33227956Baiou 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.
PubMed 33561503Karruli 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.
PubMed 33600262Patel 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.
PubMed 33565961Austin PC, Fine JP. Practical recommendations for reporting Fine-Gray model analyses for competing risk data. Stat Med. 2017 Nov 30;36(27):4391-4400. doi: 10.1002/sim.7501. Epub 2017 Sep 15.
PubMed 28913837Amorim LD, Cai J. Modelling recurrent events: a tutorial for analysis in epidemiology. Int J Epidemiol. 2015 Feb;44(1):324-33. doi: 10.1093/ije/dyu222. Epub 2014 Dec 9.
PubMed 25501468
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05293418
- Acronym / sponsor ID
- MDR_in_Fiera / 701_2021
- Conditions
- COVID-19, Bacterial Infections, Colonization, Asymptomatic
- Keywords
- COVID-19, mechanical ventilation, multidrug resistance, MDR colonization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU mechanically ventilated COVID-19 patients | – | Other: data collectionPatients admitted to Milano Fiera ICU for COVID-19 requiring mechanical ventilation from October 2020 through May 2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated COVID-19 patients admitted to Milano Fiera ICU from October 2020 through May 2021
Key inclusion criteria (2 listed)
- COVID-19-related respiratory failure
- Mechanical ventilation at least 48 hours
Key exclusion criteria (3 listed)
- Age < 18 years
- ICU stay < 48 hours
- Concurrent participation in other clinical trials is not a criterion for exclusion from this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectiondata collection from medical records and the microbiological surveillance system of the enrolled patients | Other | ICU mechanically ventilated COVID-19 patients |
Primary outcome
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.
2 secondary outcomes
Incidence of bacterial infections
Time frame: 1000 patient days
risk factors for MDRO colonization and bacterial infections
Time frame: 1000 patient days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 32091533Wu 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.
- Background: PubMed 32167538Grasselli 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.
- Background: PubMed 32203977Onder 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.
- Background: PubMed 32105632Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
- Background: PubMed 33857475Grasselli 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.
- Background: PubMed 33388794Rouze 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.
- Background: PubMed 33227956Bogossian 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.
- Background: PubMed 33561503Baiou 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.
- Background: PubMed 33600262Karruli 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.
- Background: PubMed 33565961Patel 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.
- Background: PubMed 28913837Austin PC, Fine JP. Practical recommendations for reporting Fine-Gray model analyses for competing risk data. Stat Med. 2017 Nov 30;36(27):4391-4400. doi: 10.1002/sim.7501. Epub 2017 Sep 15.
- Background: PubMed 25501468Amorim LD, Cai J. Modelling recurrent events: a tutorial for analysis in epidemiology. Int J Epidemiol. 2015 Feb;44(1):324-33. doi: 10.1093/ije/dyu222. Epub 2014 Dec 9.
- Individual participant dataSharing planned: Undecided. Anonymized data will be shared upon written request to the study director
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianpaola Monti, MD principal investigator
Intensive Care Unit, ASST Grande Ospedale Metropolitano Niguarda - Milano (Italy)
Andrea Gori, MD principal investigator
Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation - Milano (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Bacterial Infections, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MDRO colonization (time frame: 1000 patient days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05293418, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.