Identification of Gut Microbiome Biomarkers Associated to Acquisition of Enterobacteriae Highly Resistant to Third Generation Cephalosporines Following Ceftriaxone Treatment.

NCT03569917 | Terminated

• 1 other identifier: RC17_0462
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

Patients receiving Ceftriaxone 1 gram or 2 grams per day during their presence in emergency unit of hospital whatever their medical condition, will be included. Rectal swabs will be collected at inclusion and at days 5 and 30 to perform analysis. Analysis will be performed to characterize gut microbiome in order to detect intestinal microbiome profiles significantly associated with protection against colonization by third generation cephalosporin resistant Enterobacteriae.

Conditions

Patients Receiving Ceftriaxone in Hospital Emergency Unit

Outcome Measures

Primary Outcomes (1)

• Identification of gut microbiome biomarkers

  The use of culture-independent techniques, metagenomics and metabolomics, will allow an exhaustive analysis of the intestinal microbiome in order to detect intestinal microbiome profiles (including species, modules, metabolites) significantly associated with protection against colonization by Enterobacteriae resistant to Cephalosporine. Acquisition of a risk index to Enterobacteriae resistance to third generation cephalosporin will be measured by the method developed by Montassier et al, 2016, Genome medicine.

  30 days

Secondary Outcomes (1)

• Identification of gut microbiome biomarkers

  5 days

Study Arms (1)

patient under Ceftriaxone treatment

EXPERIMENTAL

Other: Rectal swab collection

Interventions

Rectal swab collection OTHER

Rectab swab collection will be performed at inclusion and 5 and 30 days later.

patient under Ceftriaxone treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years
• Able to comply with study requirement and to provide informed consent
• Outside the context of tutorship and / or guardianship, affiliated to the Social Security Regime and having consented to participate in the ARCMI study.
• Patient receiving ceftriaxone (1 gram or 2 grams per day) in the emergency department

You may not qualify if:

• Patients with acute anorectal pathology incompatible with the swabbing strategy or digital rectal examination.
• Prescription of another dosage of ceftriaxone (more than 2 grams per day)
• Patient with inflammatory bowel disease
• Allergy or contraindication to betalactamines and cephalosporins

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes university Hospital

Nantes, 44093, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 26, 2018
• Study Start: December 19, 2018
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)