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COVID-19 and ICU-acquired MDR Bacteria (COVID-BMR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378842
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
This multicenter before-after study aimed to determine the impact of infection related to SARS-CoV-2 on the incidence of ICU-acquired multidrug resistant (MDR) bacteria.

Condition or disease
Sars-CoV2 Critical Illness

Detailed Description:
Multicenter observational before-after study, aiming to determine the impact of infection related to SARS-CoV-2 on the incidence of ICU-acquired colonization and infection related to MDR bacteria.

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Study Type : Observational
Estimated Enrollment : 690 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of SARS-CoV-2 Infection on the Incidence of ICU Acquired Colonization Related to Multidrug-resistant Bacteria
Actual Study Start Date : May 18, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021



Primary Outcome Measures :
  1. Cumulative incidence of ICU-acquired colonization related multidrug resistant bacteria [ Time Frame: from D3 until day 28 after ICU admission ]
    percentage of patients with ICU acquired MDR bacteria colonization


Secondary Outcome Measures :
  1. Cumulative incidence of ICU-acquired infection related to multidrug resistant bacteria [ Time Frame: from D3 until day 28 after ICU admission ]
    percentage of patients with ICU acquired MDR bacteria infection

  2. Mechanical ventilation duration [ Time Frame: from D1 until day 28 after ICU admission ]
    the number of days Under mechanical ventilation

  3. mortality [ Time Frame: from D1 until day 28 after ICU admission ]
    death in the ICU

  4. length of stay in intensive care unit [ Time Frame: from D1 until day 28 after ICU admission ]
    the number of days of hospitalization in the ICU



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients admitted to intensive care
Criteria

Inclusion Criteria:

  • Expected ICU stay > 48 hours
  • Rectal and nasal BMR screening performed < 48 hours after admission to ICU

Exclusion Criteria:

  • Patients aged < 18 years Refusal to take part in the study ICU-stay < 48 hours At least a second rectal and nasal BMR screening was not performed prior to ICU discharge (a posteriori exclusion criterion).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378842


Contacts
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Contact: Saad Nseir, MD,PhD 3.20.44.44.95 ext +33 saadalla.nseir@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, ICU, CHU Lille Recruiting
Lille, France, 59037
Contact    0320445962      
Principal Investigator: Saad NSEIR, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Saad Nseir, MD,PhD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04378842    
Other Study ID Numbers: 2020_37
2020-A01157-32 ( Other Identifier: ID-RCB number,ANSM )
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Covid-19
Critically ill patients
multidrug-resistant bacteria
infection
colonization
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes