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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03569917

Acronym

ARCMI

Enrollment

143

Registered

2018-06-26

Start date

2018-12-19

Completion date

2022-09-19

Last updated

2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Receiving Ceftriaxone in Hospital Emergency Unit

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.

Interventions

OTHERRectal swab collection

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Identification of gut microbiome biomarkers	5 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026