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

N

Nantes University Hospital (NUH)

Status

Terminated

Conditions

Patients Receiving Ceftriaxone in Hospital Emergency Unit

Treatments

Other: Rectal swab collection

Study type

Interventional

Funder types

Other

Identifiers

NCT03569917
RC17_0462

Details and patient eligibility

About

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.

Enrollment

143 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

143 participants in 1 patient group

patient under Ceftriaxone treatment
Experimental group
Treatment:
Other: Rectal swab collection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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