Sars-CoV2COVID-BMRNCT04378842
COVID-19 and ICU-acquired MDR Bacteria
An observational study of Sars-CoV2 and Critical Illness, run by University Hospital, Lille at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2, Critical Illness
- How many people
- 368 participants
- Where
- 7 sitesFrance
- Study dates
- 18 May 2020to 26 Jul 2021
- Phase
- Observational
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: patients admitted to intensive care
Who may be able to join
- Expected ICU stay > 48 hours
- Rectal and nasal BMR screening performed < 48 hours after admission to ICU
Who cannot join
- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Chu Amiens Picardie
Amiens
Ch Bethune
Béthune
Grand Hopital de L'Est Francilien
Jossigny
CH LENS
Lens
Hôpital Roger Salengro, ICU, CHU Lille
Lille, 59037
Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)
Lyon
Hospices Civils de Lyon
Lyon
About this study
Official title: Impact of SARS-CoV-2 Infection on the Incidence of ICU Acquired Colonization Related to Multidrug-resistant Bacteria
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.
Read the 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.
- Conditions
- Sars-CoV2, Critical Illness
- Keywords
- Covid-19, Critically ill patients, multidrug-resistant bacteria, infection, colonization
- Medical subject headings
- Critical Illness, COVID-19, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of ICU-acquired colonization related multidrug resistant bacteria
percentage of patients with ICU acquired MDR bacteria colonization
Measured: from D3 until day 28 after ICU admission
Secondary outcomes (4)
Cumulative incidence of ICU-acquired infection related to multidrug resistant bacteria
percentage of patients with ICU acquired MDR bacteria infection
Measured: from D3 until day 28 after ICU admission
Mechanical ventilation duration
the number of days Under mechanical ventilation
Measured: from D1 until day 28 after ICU admission
mortality
death in the ICU
Measured: from D1 until day 28 after ICU admission
length of stay in intensive care unit
the number of days of hospitalization in the ICU
Measured: from D1 until day 28 after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start18 May 2020
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad Nseir, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378842
- Sponsor's protocol ID
- 2020_37
- Other IDs
- 2020-A01157-32
- Acronym
- COVID-BMR
- Status last verified
- Oct 2022
- First submitted
- 5 May 2020
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kreitmann L, Jermoumi S, Vasseur M, Chabani M, Nourry E, Richard JC, Wallet F, Garcon P, Kachmar S, Zerbib Y, Van Grunderbeeck N, Vinsonneau C, Duhamel A, Labreuche J, Nseir S. Relationship between COVID-19 and ICU-acquired colonization and infection related to multidrug-resistant bacteria: a prospective multicenter before-after study. Intensive Care Med. 2023 Jul;49(7):796-807. doi: 10.1007/s00134-023-07109-5. Epub 2023 Jun 16.
PubMed 37326645