Clinical trial NCT04131569: Gut Microbiota Association With ESBL-E Colonisation and Subsequent ESBL-E Infection
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Extended Spectrum Beta-Lactamase Producing Bacteria Infection
Microbial Colonization
Critical Illness
Keywords: ESBL-E
fecal carriage
microbiota
nosocomial infection
Lead sponsor: University of Bordeaux
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every in-patients admitted to our medical intensive care unit

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gut bacteriobiota diversity according to ESBL specie
timeFrame: at positive screening
Secondary outcomes:
measure: Gut mycobiota diversity according to ESBL specie
timeFrame: at positive screening
measure: Gut bacteriobiota diversity according to ESBL specie
timeFrame: at positive screening
measure: Gut mycobiota diversity according to ESBL specie
timeFrame: at positive screening
measure: bacteria and the absence of ESBL E. coli fecal carriage
timeFrame: at admission
measure: fungi and the absence of ESBL E. coli fecal carriage
timeFrame: at admission
measure: fungi and the absence of ESBL K. pneumoniae fecal carriage
timeFrame: at admission
measure: bacteria and the absence of ESBL K. pneumoniae fecal carriage
timeFrame: at admission
measure: Gut bacteriobiota and subsequent ESBL-E infection
timeFrame: at admission
measure: Gut bacteriobiota and subsequent ESBL-E infection
timeFrame: at admission
measure: Gut mycobiota and subsequent ESBL-E infection
timeFrame: at admission
measure: Gut mycobiota and subsequent ESBL-E infection
timeFrame: at admission
measure: Bacteria and the absence of subsequent ESBL-E infection
timeFrame: at admission
measure: Fungi and the absence of subsequent ESBL-E infection
timeFrame: at admission
Other outcomes:
measure: Association of gut bacteriobiota with ventilator-associated pneumonia
timeFrame: at admission
measure: Association of gut bacteriobiota with intensive care unit mortality
timeFrame: at admission
Locations:
city: Bordeaux
country: France
facility: Medical intensive care unit, Pelelgrin hospital
state: Nouvelle-Aquitaine
Study officials:
References: