Critically IllEB3REANCT04528043
Infections and Colonization With the Third Group of Enterobacteriaceae in the Intensive Care Unit
An observational study of Critically Ill and Enterobacteriaceae Infections, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
There is a lack of data whether colonization and infection with Enterobacteriaceae of the third group (EB3) affect the outcomes for ICU patients. This study evaluated the effects of EB3 colonization and infection on ICU mortality, ICU length of stay (LOS) and broad-spectrum antibiotic exposure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Enterobacteriaceae Infections, Antibiotic Resistant Infection
- How many people
- 179 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2017to 31 Dec 2019
- 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: All adults (≥ 18 years-old) patients admitted in the participating ICUs with LOS ≥ 24 hours during the study period were enrolled if they had presented a colonization and/or an infection caused by an EB3 (Enterobacter cloacae, Enterobacter aerogenes, Morganella morganii, Serratia marcescens, Hafnia alvei et Citrobacter freundii), from 1st January 2016 to 31th December 2016. Participating ICUs of the university hospital of Nancy: * two Medical ICU * 3 surgical ICU
Who may be able to join
- adults critically ill patients admitted to the the participating ICUs during the study period
- with colonization and/or infection with a third group enterobacteriacea
- and with a lenght of stay > 24h
Who cannot join
- minors patients
- lenght of stay < 24h
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infections and Colonization With the Third Group of Enterobacteriaceae in the Intensive Care Impact on the Mortality and Morbidity
There is a lack of data whether colonization and infection with Enterobacteriaceae of the third group (EB3) affect the outcomes for ICU patients. This study evaluated the effects of EB3 colonization and infection on ICU mortality, ICU length of stay (LOS) and broad-spectrum antibiotic exposure. We focused on the sub type Enterobacter regarding its a priori higher risk of resistance.
- Keywords
- Third group Enterobacteriaceae, infection, colonization, resistance, AMPc cephalosporinase
- Medical subject headings
- Critical Illness, Enterobacteriaceae Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| critically ill patients | critically ill patients admitted in one of the 5 ICUs of the university hospital of Nancy during the year 2016 with documented third group enterobacteriaceae infection and/or colonization with third group enterobacteriaceae |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Evaluation of the impact of colonization and/or infection with third group enterobacteriaceae on mortality during hospitalization and up to 180 day
Measured: Day 180
Secondary outcomes (1)
Resistance strains of sub type enterobacter
Evaluation of number of resistant strains among Enterobacter subtype in comparison with other third group enterobacteriaceae
Measured: DAY 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Apr 2017
- Primary completion10 Jan 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528043
- Sponsor's protocol ID
- PSS2018/EB3REA-NOVY/YB
- Acronym
- EB3REA
- Status last verified
- Feb 2020
- First submitted
- 24 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infections and Colonization With the Third Group of Enterobacteriaceae in the Intensive Care Impact on the Mortality and Morbidity
- ClinicalTrials.gov ID
- NCT04528043
- Acronym / sponsor ID
- EB3REA / PSS2018/EB3REA-NOVY/YB
- Keywords
- Third group Enterobacteriaceae, infection, colonization, resistance, AMPc cephalosporinase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Aug 2020 (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.
There is a lack of data whether colonization and infection with Enterobacteriaceae of the third group (EB3) affect the outcomes for ICU patients. This study evaluated the effects of EB3 colonization and infection on ICU mortality, ICU length of stay (LOS) and broad-spectrum antibiotic exposure. We focused on the sub type Enterobacter regarding its a priori higher risk of resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill patients | – | –critically ill patients admitted in one of the 5 ICUs of the university hospital of Nancy during the year 2016 with documented third group enterobacteriaceae infection and/or colonization with third group enterobacteriaceae |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults (≥ 18 years-old) patients admitted in the participating ICUs with LOS ≥ 24 hours during the study period were enrolled if they had presented a colonization and/or an infection caused by an EB3 (Enterobacter cloacae, Enterobacter aerogenes, Morganella morganii, Serratia marcescens, Hafnia alvei et Citrobacter freundii), from 1st January 2016 to 31th December 2016. Participating ICUs of the university hospital of Nancy: * two Medical ICU * 3 surgical ICU
Key inclusion criteria (3 listed)
- adults critically ill patients admitted to the the participating ICUs during the study period
- with colonization and/or infection with a third group enterobacteriacea
- and with a lenght of stay > 24h
Key exclusion criteria (2 listed)
- minors patients
- lenght of stay < 24h
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
all cause mortality
Time frame: Day 180
Evaluation of the impact of colonization and/or infection with third group enterobacteriaceae on mortality during hospitalization and up to 180 day
1 secondary outcome
Resistance strains of sub type enterobacter
Time frame: DAY 90
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 27 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Critically Ill
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Enterobacteriaceae Infections, run by Central Hospital, Nancy, France at 1 site 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 3 inclusion and 2 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 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
all cause mortality (time frame: Day 180). 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 27 Aug 2020.