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
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2019
CompletedFirst Submitted
Initial submission to the registry
October 16, 2019
CompletedFirst Posted
Study publicly available on registry
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedOctober 21, 2019
October 1, 2019
5 months
October 16, 2019
October 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Gut mycobiota diversity according to ESBL specie
at positive screening
Gut bacteriobiota diversity according to ESBL specie
at positive screening
Gut mycobiota diversity according to ESBL specie
at positive screening
bacteria and the absence of ESBL E. coli fecal carriage
at admission
fungi and the absence of ESBL E. coli fecal carriage
at admission
- +8 more secondary outcomes
Other Outcomes (2)
Association of gut bacteriobiota with ventilator-associated pneumonia
at admission
Association of gut bacteriobiota with intensive care unit mortality
at admission
Study Arms (2)
ESBL-E fecal carriers
Patients with a positive ESBL-E fecal carriage according to routine screening
non ESBL-E fecal carriers
Patients without positive ESBL-E fecal carriage according to routine screening
Interventions
ESBL-E fecal carriage screening according to routine care
Eligibility Criteria
Every in-patients admitted to our medical intensive care unit
You may qualify if:
- 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
You may not qualify if:
- Guardianship, curatorship, or prisoners
- No health insurance
- No legal representative
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical intensive care unit, Pelelgrin hospital
Bordeaux, Nouvelle-Aquitaine, 33000, France
Related Publications (1)
Prevel R, Enaud R, Orieux A, Camino A, Sioniac P, M'Zali F, Dubois V, Berger P, Boyer A, Delhaes L, Gruson D. Bridging gut microbiota composition with extended-spectrum beta-lactamase Enterobacteriales faecal carriage in critically ill patients (microbe cohort study). Ann Intensive Care. 2023 Apr 4;13(1):25. doi: 10.1186/s13613-023-01121-0.
PMID: 37014580DERIVED
Biospecimen
rectal swabs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
October 16, 2019
First Posted
October 18, 2019
Study Start
October 15, 2019
Primary Completion
March 15, 2020
Study Completion
March 15, 2020
Last Updated
October 21, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share