Back to resultsIdentification of Gut Microbiome Biomarkers Associated to Acquisition of Enterobacteriae Highly Resistant to Third Generation Cephalosporines Following Ceftriaxone Treatment. (ARCMI)
Primary Purpose
Patients Receiving Ceftriaxone in Hospital Emergency Unit
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rectal swab collection
Sponsored by
About this trial
This is an interventional basic science trial for Patients Receiving Ceftriaxone in Hospital Emergency Unit
Eligibility Criteria
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
Sites / Locations
- Nantes university Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient under Ceftriaxone treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Identification of gut microbiome biomarkers
Full Information
NCT ID
NCT03569917
First Posted
June 15, 2018
Last Updated
September 26, 2022
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03569917
Brief Title
Identification of Gut Microbiome Biomarkers Associated to Acquisition of Enterobacteriae Highly Resistant to Third Generation Cephalosporines Following Ceftriaxone Treatment.
Acronym
ARCMI
Official Title
Identification of Gut Microbiome Biomarkers Associated to Acquisition of Enterobacteriae Highly Resistant to Third Generation Cephalosporines Following Ceftriaxone Treatment.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
143 patients have been recruited instead of 150 but the theoretical date of end of inclusions being reached, we have decided to not prolong again the study.
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
September 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Receiving Ceftriaxone in Hospital Emergency Unit
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient under Ceftriaxone treatment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Rectal swab collection
Intervention Description
Rectab swab collection will be performed at inclusion and 5 and 30 days later.
Primary Outcome Measure Information:
Title
Identification of gut microbiome biomarkers
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Identification of gut microbiome biomarkers
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nantes university Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Identification of Gut Microbiome Biomarkers Associated to Acquisition of Enterobacteriae Highly Resistant to Third Generation Cephalosporines Following Ceftriaxone Treatment.
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