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

Study Overview
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Brief Summary
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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.

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

Conditions
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Patients Receiving Ceftriaxone in Hospital Emergency Unit

Intervention / Treatment
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* Other: Rectal swab collection


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient under Ceftriaxone treatment<br> | Other: Rectal swab collection<br>* Rectab swab collection will be performed at inclusion and 5 and 30 days later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of gut microbiome biomarkers |  | 5 days |