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

NCT02031588 | Terminated

• 1 other identifier: RAFREU53
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bacterial Infections

Keywords

Study of commensal flora; Fluoroquinolones

Outcome Measures

Primary Outcomes (1)

• Describe the changes in the composition of the gut microbial flora in relation to the initial flora (T0) in patients receiving antibiotics, by date of sampling, treatment received, dose, duration of therapy, ward, and duration of hospital stay.

  The primary endpoint is the change in composition of the microbial flora in relation to the initial flora (T0), at the exit of the hospital or at the end of treatment if occurs while the patient is still hospitalized (bis T0, T1, T1 bis), 3 months after the end of treatment (T2) and one year after the end of treatment (T3).

  1 year

Secondary Outcomes (1)

• A secondary endpoint is to describe the changes in the gut microbiota of hospitalized patients not receiving antibiotics.

  1 year

Study Arms (4)

Ceftriaxone

Patients receiving a C3G (ceftriaxone) during the hospitalization.

Ceftriaxone + Fluoroquinolone

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

Fluoroquinolones

fluoroquinolones (levofloxacin, ofloxacin, moxifloxacin or ciprofloxacin).

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Hospitalized patients treated with ceftriaxone and / or an oral fluoroquinolone at Beaujon hospital, Clichy, France. * A reference group of hospitalized patients not receiving antibiotics, hospitalized in the same wards as the treated patients

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Beaujon

Clichy, 92110, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples will be collected on 4 separate days for patients treated with antibiotics: T0: before treatment begins T1: at the end of treatment or discharge from the hospital T2: 3-6 months after the end of treatment T3: 10-14 months after the end of treatment For patients receiving sequentially ceftriaxone followed by a FQ, an additional sample will be collected at the end of ceftriaxone treatment. In the reference group, stool samples will be collected: T0: at inclusion in the study T1: at hospital discharge The purpose is to study the bacterial DNA contained in the stool. No analysis will be performed on the human patient DNA. Changes in the gut microflora will be analysed by metagenomics deep sequencing performed by Dushko Ehrlich (INRA, France).

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Victoire De Latours, Doctor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-11

Locations

FR (1)