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

Patients Receiving Ceftriaxone in Hospital Emergency Unit Clinical Trial

— ARCMI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03569917
• Other study ID #: RC17_0462
• Status: Terminated
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: September 19, 2022

Study information

• Verified date: September 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 143
• Est. completion date: September 19, 2022
• Est. primary completion date: September 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Patients Receiving Ceftriaxone in Hospital Emergency Unit

Intervention

Other:
• Rectal swab collection
Rectab swab collection will be performed at inclusion and 5 and 30 days later.

Locations

Country	Name	City	State
France	Nantes university Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Identification of gut microbiome biomarkers		5 days