NCT04378842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

May 18, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2021

Completed
Last Updated

April 22, 2026

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

May 5, 2020

Last Update Submit

April 17, 2026

Conditions

Sars-CoV2Critical Illness

Keywords

Covid-19Critically ill patientsmultidrug-resistant bacteriainfectioncolonization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Cumulative incidence of ICU-acquired infection related to multidrug resistant bacteria

    from D3 until day 28 after ICU admission

  • Mechanical ventilation duration

    from D1 until day 28 after ICU admission

  • mortality

    from D1 until day 28 after ICU admission

  • length of stay in intensive care unit

    from D1 until day 28 after ICU admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted to intensive care

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chu Amiens Picardie

Amiens, France

Location

Ch Bethune

Béthune, France

Location

Grand Hopital de L'Est Francilien

Jossigny, France

Location

CH LENS

Lens, France

Location

Hôpital Roger Salengro, ICU, CHU Lille

Lille, 59037, France

Location

Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)

Lyon, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Related Publications (1)

  • 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.

    PMID: 37326645RESULT

MeSH Terms

Conditions

Critical IllnessCOVID-19Infections

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Saad Nseir, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 7, 2020

Study Start

May 18, 2020

Primary Completion

July 26, 2021

Study Completion

July 26, 2021

Last Updated

April 22, 2026

Record last verified: 2022-10

Locations

FR(7)