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

Critical Care Clinical Trial

— CIMDREA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043793
• Other study ID #: 2018_07
• Secondary ID: 2018-A02756-49
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Critical Care
• Immunocompromised Host
• Infections

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