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

NCT ID: NCT03569917

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2022-09-19

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.

Detailed Description

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Conditions

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Patients Receiving Ceftriaxone in Hospital Emergency Unit

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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patient under Ceftriaxone treatment

Group Type EXPERIMENTAL

Rectal swab collection

Intervention Type OTHER

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

Interventions

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Rectal swab collection

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes university Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC17_0462

Identifier Type: -

Identifier Source: org_study_id

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