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Gut Microbiota Association With ESBL-E Colonisation and Subsequent ESBL-E Infection

Association of Gut Microbiota Diversity With Extended-spectrum Beta-lactamase Producing Enterobacteriales Fecal Carriage and Subsequent Infection in Intensive Care Unit: Microbe Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04131569
Acronym
Microbe
Enrollment
60
Registered
2019-10-18
Start date
2019-10-15
Completion date
2020-03-15
Last updated
2019-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Extended Spectrum Beta-Lactamase Producing Bacteria Infection, Microbial Colonization

Keywords

ESBL-E, fecal carriage, microbiota, nosocomial infection

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTESBL-E fecal carriage screening according to routine care

ESBL-E fecal carriage screening according to routine care

Sponsors

University of Bordeaux
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Guardianship, curatorship, or prisoners * No health insurance * No legal representative

Design outcomes

Primary

MeasureTime frameDescription
Gut bacteriobiota diversity according to ESBL specieat positive screeningComparison of gut bacteriobiota alpha diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers

Secondary

MeasureTime frameDescription
Gut mycobiota diversity according to ESBL specieat positive screeningComparison of gut mycobiota alpha diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers
fungi and the absence of ESBL K. pneumoniae fecal carriageat admissionAssociation of fungi with the absence of ESBL K. pneumoniae fecal carriage by LefSe method
Gut bacteriobiota diversity according to ESBL specieat positive screeningAnalysis of gut bacteriobiota beta diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers
bacteria and the absence of ESBL E. coli fecal carriageat admissionAssociation of bacteria with the absence of ESBL E. coli fecal carriage by LefSe method
fungi and the absence of ESBL E. coli fecal carriageat admissionAssociation of fungi with the absence of ESBL E. coli fecal carriage by LefSe method
Bacteria and the absence of subsequent ESBL-E infectionat admissionAssociation of bacteria with ESBL-E subsequent infection among ESBL-E fecal carriers by LefSe method
Fungi and the absence of subsequent ESBL-E infectionat admissionAssociation of fungi with ESBL-E subsequent infection among ESBL-E fecal carriers by LefSe method
bacteria and the absence of ESBL K. pneumoniae fecal carriageat admissionAssociation of bacteria with the absence of ESBL K. pneumoniae fecal carriage by LefSe method
Gut bacteriobiota and subsequent ESBL-E infectionat admissionComparison of gut bacteriobiota alpha diversity between ESBL-E fecal carriers subsequently ESBL-E infected and non-subsequently ESBL-E infected.
Gut mycobiota and subsequent ESBL-E infectionat admissionComparison of gut mycobiota alpha diversity between ESBL-E fecal carriers subsequently ESBL-E infected and non-subsequently ESBL-E infected.

Other

MeasureTime frameDescription
Association of gut bacteriobiota with ventilator-associated pneumoniaat admissionPatients with oro-tracheal intubation for more than 48 hours among those included will be included in this ancillary analysis. Association of alpha and beta diversities for both gut bacteriobiota and mycobiota with subsequent ventilator-associated pneumoniae will be assessed
Association of gut bacteriobiota with intensive care unit mortalityat admissionAssociation of alpha and beta diversities for both gut bacteriobiota and mycobiota with subsequent intensive care unit mortality will be assessed

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026