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Impact of Ceftriaxone and/or Fluoroquinolone (FQ) Treatment on the Gut Microbiota of Hospitalized Patients.

NCT ID: NCT02031588

Last Updated: 2015-12-09

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

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-09-30

Brief Summary

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Observational study of the effects of antibiotics on commensal flora. Realization of stool samples and nasal swabs before and after antibiotic therapy.

Detailed Description

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The emergence of resistance to fluoroquinolone (FQ) and is a major problem worldwide. The commensal flora is the main reservoir for antibiotic resistance. Understanding the factors (environmental, patient-related, dosis-related, drug-related…) involved in the emergence of resistance to fluoroquinolones in the commensal flora of patients treated with a FQ, may help prevent it and preserve the efficiency of these important antibiotics. Samples of digestive flora will be collected from hospitalized patients before receiving a FQ or Ceftriaxone, at the end of the treatment and 3 month after the end of treatment. Clinical data will be collected.

Conditions

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Bacterial Infections

Keywords

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Study of commensal flora Fluoroquinolones

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ceftriaxone

Patients receiving a C3G (ceftriaxone) during the hospitalization.

No interventions assigned to this group

Ceftriaxone + Fluoroquinolone

ceftriaxone followed by fluoroquinolone (which is a common situation in clinical practice, Fluoroquinolone being prescribed after obtaining antibiogram).

No interventions assigned to this group

Fluoroquinolones

fluoroquinolones (levofloxacin, ofloxacin, moxifloxacin or ciprofloxacin).

No interventions assigned to this group

Reference

A third reference group will consist of patients hospitalized in the same services as the "case" patients but did not receive antibiotics (60 patients). They will have an idea of possible changes in flora during hospitalization without any antibiotics, for example due to horizontal transfer of resistant strains. This group will be composed of 60 patients who had not received antibiotics within 3 months before and not receiving for the duration of their participation.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patient hospitalized in a participating ward of the hospital for an expected duration of more than 24 hours.
* Treatment by ceftriaxone and / or a fluoroquinolone started by the attending physicians during hospitalization.
* No hospitalization or stay in nursing home in the previous three months.
* No use of antibiotics in the last 3 months
* Not receiving other antibiotics than ceftriaxone or FQ
* Informed consent


* Adult patient hospitalized in a participating ward of the hospital for an expected duration of more than 24 hours.
* Not receiving any antibiotic and not expected to receive any during hospitalization
* No hospitalization or stay in nursing home in the previous three months.
* No use of antibiotics in the last 3 months
* Informed consent

Exclusion Criteria

* Pregnant or nursing women
* Patient who underwent colectomy or suffering from chronic intestinal disease (inflammatory intestinal disease or short bowel syndrome)
* Patient who used a bowel preparation solution for colonoscopy during hospitalization or in the previous week.
* Protected adult patient (deputyship or guardianship)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoire De Latours, Doctor

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Beaujon

Clichy, , France

Site Status

Countries

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France

Other Identifiers

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RAFREU53

Identifier Type: -

Identifier Source: org_study_id