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Completed

NCT Number: NCT04043793

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

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.

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Key information

Conditions

Immunocompromised Host Critical Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Amiens Picardie, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: From ICU admission until day 28 after ICU admission

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

Secondary outcomes

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

    Time frame: From ICU admission until day 28 after ICU admission

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

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

    Time frame: From ICU admission until day 28 after ICU admission

    The rate of patients with at least one ICU-acquired colonization related to MDR

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

    Time frame: From ICU admission until day 28 after ICU admission

    The rate of patients with at least one ICU-acquired infection related to MDR

  4. 28 day mortality

    Time frame: from ICU admission until day 28 after admission

    death in the ICU or after discharge from the ICU

  5. Mechanical ventilation duration

    Time frame: From ICU admission until day 28 after ICU admission

    the number of days Under mechanical ventilation

  6. length of stay in intensive care unit

    Time frame: From ICU admission until day 28 after ICU admission

    the number of days of hospitalization in teh ICU

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Intensive Care Unit (ICU)-Acquired Colonization and Infection Related to Multidrug Resistant Bacteria (MDR) in Immunocompromised Patients

Acronym: CIMDREA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2019
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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