ICU-acquired Colonization and Infection Related to MDR in Immunocompromised Patients

NCT04043793 | Completed

• 2 other identifiers: 2018_072018-A02756-49
• Study Type: observational
• Target: 759
• Locations: 1 country
• Sites: 7

Brief Summary

the number of immunocompromised patients hospitalized in the intensive care units (ICU) is increasing. They are at higher risk of colonization and/or infection with multi-resistant bacteria (MDR). However this risk is not well characterized. ICU acquired infections related to MDR are associated with increased morbidity and mortality. The aim of this study is to compare the incidence of ICU-acquired colonization and ICU-acquired infection related to MDR between immunocompromized and immunocompetent patients. The risk factors for ICU-acquired colonization and ICU-acquired infections, and their impact on outcome will also be evaluated and compared between immunocompromised and immunocompetent patients.

Conditions

Immunocompromised Host; Critical Care

Keywords

Immunocompromised Host; Critical care; Drug Resistance, Multiple

Outcome Measures

Primary Outcomes (1)

• Density rate of ICU-acquired infections related to MDR in immunosuppressed patients.

  the number ICU-acquired infections related to MDR will be devided by the number of days in the ICU and reported for 1000 days.

  From ICU admission until day 28 after ICU admission

Secondary Outcomes (6)

• Density rate of ICU-acquired colonizations related to MDR in immunosuppressed patients

  From ICU admission until day 28 after ICU admission

• Rate of ICU-acquired colonizations related to MDR in immunosuppressed patients.

  From ICU admission until day 28 after ICU admission

• Rate of ICU-acquired infections related to MDR in immunosuppressed patients

  From ICU admission until day 28 after ICU admission

• 28 day mortality

  from ICU admission until day 28 after admission

• Mechanical ventilation duration

  From ICU admission until day 28 after ICU admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

immunocompetent patients, and immunocompromised patients admitted to intensive care

You may qualify if:

• Expected ICU stay \> 48 hours
• All patients (immunocompromised or immunocompetent).

You may not qualify if:

• Patients aged \< 18 years
• Refusal to take part in the study
• ICU-stay \< 48 hours
• Non availability of initial MDR or subsequent screening
• Participation in another study that could interfere with the risk of ICU-acquired colonization and infection with MDR bacteria

Sponsors & Collaborators

• University Hospital, Lille: lead

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, CHU

Lille, France

Location

Hospices Civils de Lyon

Lyon, France

Location

C.H de Roubaix

Roubaix, France

Location

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: July 3, 2019
• First Posted: August 2, 2019
• Study Start: November 7, 2019
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

FR (7)