Critical Care Clinical Trial
— CIMDREAOfficial title:
Intensive Care Unit (ICU)-Acquired Colonization and Infection Related to Multidrug Resistant Bacteria (MDR) in Immunocompromised Patients
Verified date | October 2022 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
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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