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

Not Applicable

Terminated

• Conditions: Patients Receiving Ceftriaxone in Hospital Emergency Unit
• Interventions: Other: Rectal swab collection

• Registration Number: NCT03569917
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-26
• Study Start: 2018-12-19
• Status Verified: 2022-09
• Primary Completion: 2022-09-19
• Study Completion: 2022-09-19
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient under Ceftriaxone treatment	Rectal swab collection	-

Primary Outcome Measures

Name	Time	Method
Identification of gut microbiome biomarkers	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Identification of gut microbiome biomarkers	5 days

Trial Locations

Locations (1)

Nantes university Hospital; 🇫🇷 Nantes, France