Extended Spectrum Beta-Lactamase Producing Bacteria InfectionMicrobeNCT04131569
Gut Microbiota Association With ESBL-E Colonisation and Subsequent ESBL-E Infection
An observational study of Extended Spectrum Beta-Lactamase Producing Bacteria Infection and Microbial Colonization, run by University of Bordeaux at 1 site in France.
Trial summary
Antimicrobial resistance is a major threat worldwide and extended-spectrum beta-lactamase producing Enterobacteriales (ESBL-E) are a leading cause because of their wide dissemination. Gut microbiota seems to be correlated with multi-drug resistant organism carriage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extended Spectrum Beta-Lactamase Producing Bacteria Infection, Microbial Colonization, Critical Illness
- What is being tested?
- ESBL-E fecal carriage screening according to routine care
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2019to 15 Mar 2020
- 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: Every in-patients admitted to our medical intensive care unit
Who may be able to join
- Patient above 18 year-old admitted to intensive care unit
- ESBL-E fecal carriage according to current screening recommendations for ESBL-E carriage group
- Feces quantity on rectal swab adequate for routine screening and microbiota analysis
Who cannot join
- Guardianship, curatorship, or prisoners
- No health insurance
- No legal representative
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Medical intensive care unit, Pelelgrin hospital
Bordeaux, New Aquitaine, 33000
Didier Gruson, Prof, +33556795679, didier.gruson@chu-bordeaux.fr
Renaud Prevel, MD, PhD, +33556795679, renaud.prevel@u-bordeaux.fr
About this study
Official title: Association of Gut Microbiota Diversity With Extended-spectrum Beta-lactamase Producing Enterobacteriales Fecal Carriage and Subsequent Infection in Intensive Care Unit: Microbe Study
Antimicrobial resistance is a major threat worldwide and extended-spectrum beta-lactamase producing Enterobacteriales (ESBL-E) are a leading cause because of their wide dissemination. Gut microbiota seems to be correlated with multi-drug resistant organism carriage. This study thus aims to analyse the correlation between gut microbiota, ESBL-E fecal carriage and subsequent infection.
Read the detailed description
The rising antimicrobial resistance has led to more than 33,000 deaths in Europe in 2015. Among them, extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) are the most frequent in Europe and have disseminated both in the community and in healthcare settings. Some studies have suggested that microbiota could be different between multi-drug resistant organisms, with different relative abundances of some bacteria. One study focused on ESBL-E fecal carriers, but in the community, with Bacteroides uniformis being more abundant in ESBL-E non-carriers than carriers. As identification of species discriminating between ESBL-E fecal carriers and non-carriers could pave the way for the design of ESBL-E carriage eliminating probiotics, we aim to analyse the correlation between gut microbiota and ESBL-E fecal carriage.
Moreover, mechanisms in the link between ESBL-E fecal carriage and subsequent ESBL-E infection remain, so far, poorly understood and this study aims to provide a first insight in the involvement of gut microbiota in the link between colonization and infection.
- Conditions
- Extended Spectrum Beta-Lactamase Producing Bacteria Infection, Microbial Colonization, Critical Illness
- Being tested
- ESBL-E fecal carriage screening according to routine care
- Keywords
- ESBL-E, fecal carriage, microbiota, nosocomial infection
- Medical subject headings
- Communicable Diseases, Critical Illness, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESBL-E fecal carriage screening according to routine careDiagnostic test
ESBL-E fecal carriage screening according to routine care
| Study group | Role | What they receive |
|---|---|---|
| ESBL-E fecal carriers | Patients with a positive ESBL-E fecal carriage according to routine screening Receives: Diagnostic Test: ESBL-E fecal carriage screening according to routine care | |
| non ESBL-E fecal carriers | Patients without positive ESBL-E fecal carriage according to routine screening Receives: Diagnostic Test: ESBL-E fecal carriage screening according to routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut bacteriobiota diversity according to ESBL specie
Comparison of gut bacteriobiota alpha diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers
Measured: at positive screening
Secondary outcomes (13)
Gut mycobiota diversity according to ESBL specie
Comparison of gut mycobiota alpha diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers
Measured: at positive screening
Gut bacteriobiota diversity according to ESBL specie
Analysis of gut bacteriobiota beta diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers
Measured: at positive screening
Gut mycobiota diversity according to ESBL specie
Analysis of gut mycobiota beta diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers
Measured: at positive screening
bacteria and the absence of ESBL E. coli fecal carriage
Association of bacteria with the absence of ESBL E. coli fecal carriage by LefSe method
Measured: at admission
fungi and the absence of ESBL E. coli fecal carriage
Association of fungi with the absence of ESBL E. coli fecal carriage by LefSe method
Measured: at admission
fungi and the absence of ESBL K. pneumoniae fecal carriage
Association of fungi with the absence of ESBL K. pneumoniae fecal carriage by LefSe method
Measured: at admission
bacteria and the absence of ESBL K. pneumoniae fecal carriage
Association of bacteria with the absence of ESBL K. pneumoniae fecal carriage by LefSe method
Measured: at admission
Gut bacteriobiota and subsequent ESBL-E infection
Comparison of gut bacteriobiota alpha diversity between ESBL-E fecal carriers subsequently ESBL-E infected and non-subsequently ESBL-E infected.
Measured: at admission
Gut bacteriobiota and subsequent ESBL-E infection
Analysis of gut bacteriobiota beta diversity between ESBL-E fecal carriers subsequently ESBL-E infected and non-subsequently ESBL-E infected
Measured: at admission
Gut mycobiota and subsequent ESBL-E infection
Comparison of gut mycobiota alpha diversity between ESBL-E fecal carriers subsequently ESBL-E infected and non-subsequently ESBL-E infected.
Measured: at admission
Gut mycobiota and subsequent ESBL-E infection
Analysis of gut mycobiota beta diversity between ESBL-E fecal carriers subsequently ESBL-E infected and non-subsequently ESBL-E infected
Measured: at admission
Bacteria and the absence of subsequent ESBL-E infection
Association of bacteria with ESBL-E subsequent infection among ESBL-E fecal carriers by LefSe method
Measured: at admission
Fungi and the absence of subsequent ESBL-E infection
Association of fungi with ESBL-E subsequent infection among ESBL-E fecal carriers by LefSe method
Measured: at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start15 Oct 2019
- Primary completion15 Mar 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extended Spectrum Beta-Lactamase Producing Bacteria InfectionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Pauline Esteves, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131569
- Sponsor's protocol ID
- Microbe
- Acronym
- Microbe
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prevel R, Enaud R, Orieux A, Camino A, Sioniac P, M'Zali F, Dubois V, Berger P, Boyer A, Delhaes L, Gruson D. Bridging gut microbiota composition with extended-spectrum beta-lactamase Enterobacteriales faecal carriage in critically ill patients (microbe cohort study). Ann Intensive Care. 2023 Apr 4;13(1):25. doi: 10.1186/s13613-023-01121-0.
PubMed 37014580
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Gut Microbiota Diversity With Extended-spectrum Beta-lactamase Producing Enterobacteriales Fecal Carriage and Subsequent Infection in Intensive Care Unit: Microbe Study
- ClinicalTrials.gov ID
- NCT04131569
- Acronym / sponsor ID
- Microbe / Microbe
- Conditions
- Extended Spectrum Beta-Lactamase Producing Bacteria Infection, Microbial Colonization, Critical Illness
- Keywords
- ESBL-E, fecal carriage, microbiota, nosocomial infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BordeauxUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 18 Oct 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.
Antimicrobial resistance is a major threat worldwide and extended-spectrum beta-lactamase producing Enterobacteriales (ESBL-E) are a leading cause because of their wide dissemination. Gut microbiota seems to be correlated with multi-drug resistant organism carriage. This study thus aims to analyse the correlation between gut microbiota, ESBL-E fecal carriage and subsequent infection.
Detailed description
The rising antimicrobial resistance has led to more than 33,000 deaths in Europe in 2015. Among them, extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) are the most frequent in Europe and have disseminated both in the community and in healthcare settings. Some studies have suggested that microbiota could be different between multi-drug resistant organisms, with different relative abundances of some bacteria. One study focused on ESBL-E fecal carriers, but in the community, with Bacteroides uniformis being more abundant in ESBL-E non-carriers than carriers. As identification of species discriminating between ESBL-E fecal carriers and non-carriers could pave the way for the design of ESBL-E carriage eliminating probiotics, we aim to analyse the correlation between gut microbiota and ESBL-E fecal carriage.
Moreover, mechanisms in the link between ESBL-E fecal carriage and subsequent ESBL-E infection remain, so far, poorly understood and this study aims to provide a first insight in the involvement of gut microbiota in the link between colonization and infection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESBL-E fecal carriers | – | Diagnostic Test: ESBL-E fecal carriage screening according to routine carePatients with a positive ESBL-E fecal carriage according to routine screening |
| non ESBL-E fecal carriers | – | Diagnostic Test: ESBL-E fecal carriage screening according to routine carePatients without positive ESBL-E fecal carriage according to routine screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every in-patients admitted to our medical intensive care unit
Key inclusion criteria (3 listed)
- Patient above 18 year-old admitted to intensive care unit
- ESBL-E fecal carriage according to current screening recommendations for ESBL-E carriage group
- Feces quantity on rectal swab adequate for routine screening and microbiota analysis
Key exclusion criteria (3 listed)
- Guardianship, curatorship, or prisoners
- No health insurance
- No legal representative
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 |
|---|---|---|
| ESBL-E fecal carriage screening according to routine careESBL-E fecal carriage screening according to routine care | Diagnostic test | ESBL-E fecal carriers, non ESBL-E fecal carriers |
Primary outcome
Gut bacteriobiota diversity according to ESBL specie
Time frame: at positive screening
Comparison of gut bacteriobiota alpha diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers
13 secondary outcomes
Gut mycobiota diversity according to ESBL specie
Time frame: at positive screening
Gut bacteriobiota diversity according to ESBL specie
Time frame: at positive screening
Gut mycobiota diversity according to ESBL specie
Time frame: at positive screening
bacteria and the absence of ESBL E. coli fecal carriage
Time frame: at admission
fungi and the absence of ESBL E. coli fecal carriage
Time frame: at admission
fungi and the absence of ESBL K. pneumoniae fecal carriage
Time frame: at admission
bacteria and the absence of ESBL K. pneumoniae fecal carriage
Time frame: at admission
Gut bacteriobiota and subsequent ESBL-E infection
Time frame: at admission
Gut bacteriobiota and subsequent ESBL-E infection
Time frame: at admission
Gut mycobiota and subsequent ESBL-E infection
Time frame: at admission
Gut mycobiota and subsequent ESBL-E infection
Time frame: at admission
Bacteria and the absence of subsequent ESBL-E infection
Time frame: at admission
Fungi and the absence of subsequent ESBL-E infection
Time frame: at admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Derived from this study: PubMed 37014580Prevel R, Enaud R, Orieux A, Camino A, Sioniac P, M'Zali F, Dubois V, Berger P, Boyer A, Delhaes L, Gruson D. Bridging gut microbiota composition with extended-spectrum beta-lactamase Enterobacteriales faecal carriage in critically ill patients (microbe cohort study). Ann Intensive Care. 2023 Apr 4;13(1):25. doi: 10.1186/s13613-023-01121-0.
- Individual participant dataSharing planned: No
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.
Medical intensive care unit, Pelelgrin hospital
Bordeaux, France
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 Extended Spectrum Beta-Lactamase Producing Bacteria Infection and Microbial Colonization, run by University of Bordeaux 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 3 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 21 Oct 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut bacteriobiota diversity according to ESBL specie (time frame: at positive screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04131569, which also lists 1 linked publication.
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 21 Oct 2019; AzTrials last refreshed its copy on 30 Oct 2026.