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

NCT ID: NCT04131569

Last Updated: 2019-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-15

Study Completion Date

2020-03-15

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ESBL-E fecal carriers

Patients with a positive ESBL-E fecal carriage according to routine screening

ESBL-E fecal carriage screening according to routine care

Intervention Type 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

ESBL-E fecal carriage screening according to routine care

Intervention Type DIAGNOSTIC_TEST

ESBL-E fecal carriage screening according to routine care

Interventions

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ESBL-E fecal carriage screening according to routine care

ESBL-E fecal carriage screening according to routine care

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Dr Pauline Esteves

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical intensive care unit, Pelelgrin hospital

Bordeaux, Nouvelle-Aquitaine, France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Didier Gruson, Prof

Role: primary

+33556795679

Renaud Prevel, MD, PhD

Role: backup

+33556795679

References

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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.

Reference Type DERIVED
PMID: 37014580 (View on PubMed)

Other Identifiers

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Microbe

Identifier Type: -

Identifier Source: org_study_id

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