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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04043793
Other study ID # 2018_07
Secondary ID 2018-A02756-49
Status Completed
Phase
First received
Last updated
Start date November 7, 2019
Est. completion date December 7, 2021

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 759
Est. completion date December 7, 2021
Est. primary completion date December 7, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


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, CHU Lille
France Hospices Civils de Lyon Lyon
France C.H de Roubaix Roubaix

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Density rate of ICU-acquired colonizations related to MDR in immunosuppressed patients 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 From ICU admission until day 28 after ICU admission
Secondary Rate of ICU-acquired colonizations related to MDR in immunosuppressed patients. The rate of patients with at least one ICU-acquired colonization related to MDR From ICU admission until day 28 after ICU admission
Secondary Rate of ICU-acquired infections related to MDR in immunosuppressed patients The rate of patients with at least one ICU-acquired infection related to MDR From ICU admission until day 28 after ICU admission
Secondary 28 day mortality death in the ICU or after discharge from the ICU from ICU admission until day 28 after admission
Secondary Mechanical ventilation duration the number of days Under mechanical ventilation From ICU admission until day 28 after ICU admission
Secondary length of stay in intensive care unit the number of days of hospitalization in teh ICU From ICU admission until day 28 after ICU admission
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