COVID-19 and ICU-acquired MDR Bacteria

Critical Illness Clinical Trial

— COVID-BMR  

Official title:

Impact of SARS-CoV-2 Infection on the Incidence of ICU Acquired Colonization Related to Multidrug-resistant Bacteria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378842
• Other study ID #: 2020_37
• Secondary ID: 2020-A01157-32
• Status: Completed
• Start date: May 18, 2020
• Est. completion date: July 26, 2021

Study information

• Verified date: October 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Critical Illness
• Sars-CoV2

Locations

Country	Name	City	State
France	Chu Amiens Picardie	Amiens
France	Ch Bethune	Béthune
France	Grand Hopital de L'Est Francilien	Jossigny
France	CH LENS	Lens
France	Hôpital Roger Salengro, ICU, CHU Lille	Lille
France	Hospices Civils de Lyon	Lyon
France	Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of ICU-acquired colonization related multidrug resistant bacteria	percentage of patients with ICU acquired MDR bacteria colonization	from D3 until day 28 after ICU admission
Secondary	Cumulative incidence of ICU-acquired infection related to multidrug resistant bacteria	percentage of patients with ICU acquired MDR bacteria infection	from D3 until day 28 after ICU admission
Secondary	Mechanical ventilation duration	the number of days Under mechanical ventilation	from D1 until day 28 after ICU admission
Secondary	mortality	death in the ICU	from D1 until day 28 after ICU admission
Secondary	length of stay in intensive care unit	the number of days of hospitalization in the ICU	from D1 until day 28 after ICU admission