Gut Microbiota Association With ESBL-E Colonisation and Subsequent ESBL-E Infection (Microbe)

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Microbial Colonization; Extended Spectrum Beta-Lactamase Producing Bacteria Infection
• Intervention / Treatment: Diagnostic test: ESBL-E fecal carriage screening according to routine care

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Nouvelle-Aquitaine
    • Bordeaux, Nouvelle-Aquitaine, France, 33000
      • Recruiting
      • Medical intensive care unit, Pelelgrin hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Every in-patients admitted to our medical intensive care unit

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ESBL-E fecal carriers; Patients with a positive ESBL-E fecal carriage according to routine screening	Diagnostic test: ESBL-E fecal carriage screening according to routine care; 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	Diagnostic test: ESBL-E fecal carriage screening according to routine care; ESBL-E fecal carriage screening according to routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut bacteriobiota diversity according to ESBL specie	Comparison of gut bacteriobiota alpha diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers	at positive screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut mycobiota diversity according to ESBL specie	Comparison of gut mycobiota alpha diversity between ESBL E. coli and ESBL K. pneumoniae fecal carriers	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	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	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	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	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	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	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.	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	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.	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	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	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	at admission

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of gut bacteriobiota with ventilator-associated pneumonia	Patients 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	at admission
Association of gut bacteriobiota with intensive care unit mortality	Association of alpha and beta diversities for both gut bacteriobiota and mycobiota with subsequent intensive care unit mortality will be assessed	at admission

Collaborators and Investigators

• Sponsor: University of Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Anticipated): March 15, 2020
• Study Completion (Anticipated): March 15, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: microbiota; nosocomial infection; ESBL-E; fecal carriage
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Critical Illness
• Other Study ID Numbers: Microbe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No