Immunocompromised HostCIMDREANCT04043793
ICU-acquired Colonization and Infection Related to MDR in Immunocompromised Patients
An observational study of Immunocompromised Host and Critical Care, run by University Hospital, Lille at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunocompromised Host, Critical Care
- How many people
- 759 participants
- Where
- 7 sitesFrance
- Study dates
- 7 Nov 2019to 7 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: immunocompetent patients, and immunocompromised patients admitted to intensive care
Who may be able to join
- Expected ICU stay > 48 hours
- All patients (immunocompromised or immunocompetent).
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Chu Amiens Picardie
Amiens
Ch Bethune
Béthune
Grand Hopital de L'Est Francilien
Jossigny
CH LENS
Lens
Hôpital Roger Salengro, CHU
Lille
Hospices Civils de Lyon
Lyon
C.H de Roubaix
Roubaix
About this study
Official title: Intensive Care Unit (ICU)-Acquired Colonization and Infection Related to Multidrug Resistant Bacteria (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.
- Conditions
- Immunocompromised Host, Critical Care
- Keywords
- Immunocompromised Host, Critical care, Drug Resistance, Multiple
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission until day 28 after ICU admission
Secondary outcomes (6)
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
Measured: From ICU admission until day 28 after ICU admission
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
Measured: From ICU admission until day 28 after ICU admission
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
Measured: From ICU admission until day 28 after ICU admission
28 day mortality
death in the ICU or after discharge from the ICU
Measured: from ICU admission until day 28 after admission
Mechanical ventilation duration
the number of days Under mechanical ventilation
Measured: From ICU admission until day 28 after ICU admission
length of stay in intensive care unit
the number of days of hospitalization in teh ICU
Measured: From ICU admission until day 28 after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start7 Nov 2019
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunocompromised HostStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 759 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad NSEIR, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043793
- Sponsor's protocol ID
- 2018_07
- Other IDs
- 2018-A02756-49
- Acronym
- CIMDREA
- Status last verified
- Oct 2022
- First submitted
- 3 Jul 2019
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Unit (ICU)-Acquired Colonization and Infection Related to Multidrug Resistant Bacteria (MDR) in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT04043793
- Acronym / sponsor ID
- CIMDREA / 2018_07
- Conditions
- Immunocompromised Host, Critical Care
- Keywords
- Immunocompromised Host, Critical care, Drug Resistance, Multiple
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 759 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- immunocompetent patients, and immunocompromised patients admitted to intensive care
Key inclusion criteria (2 listed)
- Expected ICU stay > 48 hours
- All patients (immunocompromised or immunocompetent).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Density rate of ICU-acquired colonizations related to MDR in immunosuppressed patients
Time frame: From ICU admission until day 28 after ICU admission
Rate of ICU-acquired colonizations related to MDR in immunosuppressed patients.
Time frame: From ICU admission until day 28 after ICU admission
Rate of ICU-acquired infections related to MDR in immunosuppressed patients
Time frame: From ICU admission until day 28 after ICU admission
28 day mortality
Time frame: from ICU admission until day 28 after admission
Mechanical ventilation duration
Time frame: From ICU admission until day 28 after ICU admission
length of stay in intensive care unit
Time frame: From ICU admission until day 28 after ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saad NSEIR, MD, PhD principal investigator
University Hospital, Lille
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunocompromised Host and Critical Care, run by University Hospital, Lille at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Density rate of ICU-acquired infections related to MDR in immunosuppressed patients. (time frame: From ICU admission until day 28 after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.