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

Study Overview
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: ESBL-E fecal carriage screening according to routine care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ESBL-E fecal carriers<br>Patients with a positive ESBL-E fecal carriage according to routine screening | Diagnostic Test: ESBL-E fecal carriage screening according to routine care<br>* ESBL-E fecal carriage screening according to routine care<br>|
| non ESBL-E fecal carriers<br>Patients without positive ESBL-E fecal carriage according to routine screening | Diagnostic Test: ESBL-E fecal carriage screening according to routine care<br>* ESBL-E fecal carriage screening according to routine care<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESBL-E, fecal carriage, microbiota, nosocomial infection