Viewing Study NCT04131569


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Study NCT ID: NCT04131569
Status: UNKNOWN
Last Update Posted: 2019-10-21
First Post: 2019-10-16
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Gut Microbiota Association With ESBL-E Colonisation and Subsequent ESBL-E Infection
Sponsor: University of Bordeaux
Organization:

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2019-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Microbe
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: