Ventilator Associated PneumoniaBMREANCT04903886
Intensive Care Unit Acquired Infections in Patients Colonized With Extended Spectrum Enterobacteriaceae
An observational study of Ventilator Associated Pneumonia and Bacteremia, run by University Hospital, Brest at 1 site in France.
Trial summary
Worldwide emergence of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in ICU, with at least 10% of incidence at the admission in Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Bacteremia, Abdominal Infection
- What is being tested?
- observational
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 1 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: All patient admitted in the ICU during a 5 years period (2015-2019) with a positive rectal swab for ESBL-Enterobacteriae screening at the admission or during the ICU stay
Who may be able to join
- admitted in Brest ICU (medical or surgical)
- positive rectal swab for ESBL-Enterobacteriae screening at the admission or during the ICU stay
- written consent
Who cannot join
- refusing to participate
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU de Brest
Brest, 29609
Pierre Bailly, 0298347181, pierre.bailly@chu-brest.fr
About this study
Official title: Epidemiology of ICU-acquired Infections in Patients With Fecal Carriage of Extended Spectrum Betalactamase Enterobacteriaceae (ESBL-E)
Worldwide emergence of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in ICU, with at least 10% of incidence at the admission in Europe. A systematic rectal swab is used in 70% of French ICU to detect intestinal ESBL-E carriage The relationship between intestinal carriage and ICU-acquired infection is not perfectly known. The investigators conducted a five years study monocentric retrospective observational cohort in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate which type of infections and which bacteria are involved.
The investigators also collect data about antibiotherapy used to treat these infections.
Read the detailed description
Intestinal carriage of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in general population, morover in intensive care units. Systematic rectal swab for screening is done in 70% of French ICU in routine. Some studies had show a good negative predictive value of this test for ICU-acquired infection (for example ventilator-associated pneumoniae), but a poor predictive positive value. The precise relationship between intestinal carriage and ICU-acquired infection is not perfectly known.
Probabilist antibiotherapy with carbapenem for ESBL-E suspected infection are currently recommanded by national and european Guidelines, particulary in case of shock or immunodepression.
A ESBL-E systematic screening-guided strategy for probabilist antibiotherapy could be interesting, and could lead to a carbapenem or a carbapenem-sparing focused antibiotherapy.
The investigators conducted a monocentric retrospective observational cohort study in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate the number of ESBL-E related infections, the site of these infections and which species of bacteriae are involved. They also investigate which was the antibiotherapy administered, and investigate what factors lead clinicians to treat the infection with carbapenem antibiotherapy.
- Conditions
- Ventilator Associated Pneumonia, Bacteremia, Abdominal Infection, Enterobacteriaceae Infections
- Being tested
- observational
- Medical subject headings
- Pneumonia, Ventilator-Associated, Bacteremia, Intraabdominal Infections, Enterobacteriaceae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
observational
| Study group | Role | What they receive |
|---|---|---|
| All patient colonized with ESBL-E in Brest Intensive Care unit | All patient colonized with ESBL-E in Brest Intensive Care unit, in a 5 years period (2015-2019) Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of ESBL-E related infection in ICU-aquired infection
proportion of ESBL-E related infection in ICU-aquired infection
Measured: 28 days
Secondary outcomes (5)
use of carbapenem antibiotherapy
use of carbapenem antibiotherapy
Measured: 28 days
length of ICU-stay
length of ICU-stay
Measured: 28 days
length of hospital-stay
length of hospital-stay
Measured: 28 days
mortality rate in ICU
death in ICU
Measured: 28 days
mortality in hospital
death in hospital
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903886
- Sponsor's protocol ID
- BMREA ( 29BRC20.0019)
- Acronym
- BMREA
- Status last verified
- Feb 2021
- First submitted
- 28 Apr 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of ICU-acquired Infections in Patients With Fecal Carriage of Extended Spectrum Betalactamase Enterobacteriaceae (ESBL-E)
- ClinicalTrials.gov ID
- NCT04903886
- Acronym / sponsor ID
- BMREA / BMREA ( 29BRC20.0019)
- Conditions
- Ventilator Associated Pneumonia, Bacteremia, Abdominal Infection, Enterobacteriaceae Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 27 May 2021 (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.
Worldwide emergence of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in ICU, with at least 10% of incidence at the admission in Europe. A systematic rectal swab is used in 70% of French ICU to detect intestinal ESBL-E carriage The relationship between intestinal carriage and ICU-acquired infection is not perfectly known. The investigators conducted a five years study monocentric retrospective observational cohort in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate which type of infections and which bacteria are involved.
The investigators also collect data about antibiotherapy used to treat these infections.
Detailed description
Intestinal carriage of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in general population, morover in intensive care units. Systematic rectal swab for screening is done in 70% of French ICU in routine. Some studies had show a good negative predictive value of this test for ICU-acquired infection (for example ventilator-associated pneumoniae), but a poor predictive positive value. The precise relationship between intestinal carriage and ICU-acquired infection is not perfectly known.
Probabilist antibiotherapy with carbapenem for ESBL-E suspected infection are currently recommanded by national and european Guidelines, particulary in case of shock or immunodepression.
A ESBL-E systematic screening-guided strategy for probabilist antibiotherapy could be interesting, and could lead to a carbapenem or a carbapenem-sparing focused antibiotherapy.
The investigators conducted a monocentric retrospective observational cohort study in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate the number of ESBL-E related infections, the site of these infections and which species of bacteriae are involved. They also investigate which was the antibiotherapy administered, and investigate what factors lead clinicians to treat the infection with carbapenem antibiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patient colonized with ESBL-E in Brest Intensive Care unit | – | Other: observationalAll patient colonized with ESBL-E in Brest Intensive Care unit, in a 5 years period (2015-2019) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient admitted in the ICU during a 5 years period (2015-2019) with a positive rectal swab for ESBL-Enterobacteriae screening at the admission or during the ICU stay
Key inclusion criteria (3 listed)
- admitted in Brest ICU (medical or surgical)
- positive rectal swab for ESBL-Enterobacteriae screening at the admission or during the ICU stay
- written consent
Key exclusion criteria (1 listed)
- refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationalobservational | Other | All patient colonized with ESBL-E in Brest Intensive Care unit |
Primary outcome
proportion of ESBL-E related infection in ICU-aquired infection
Time frame: 28 days
proportion of ESBL-E related infection in ICU-aquired infection
5 secondary outcomes
use of carbapenem antibiotherapy
Time frame: 28 days
length of ICU-stay
Time frame: 28 days
length of hospital-stay
Time frame: 28 days
mortality rate in ICU
Time frame: 28 days
mortality in hospital
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
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 Ventilator Associated Pneumonia and Bacteremia, run by University Hospital, Brest 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 1 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: status not confirmed, as of the sponsor's last update on 27 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Bailly (0298347181, pierre.bailly@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of ESBL-E related infection in ICU-aquired infection (time frame: 28 days). 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 May 2021.