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

Critical Illness Clinical Trial

— Microbe  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04131569
• Other study ID #: Microbe
• Status: Recruiting
• Start date: October 15, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: October 2019
• Source: University of Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• ESBL-E fecal carriage screening according to routine care
ESBL-E fecal carriage screening according to routine care

Locations

Country	Name	City	State
France	Medical intensive care unit, Pelelgrin hospital	Bordeaux	Nouvelle-Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
University of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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