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

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

Study Overview

• Status: Terminated
• Conditions: Bacterial Infections

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• France
  • Clichy la garenne, France, 92110
    • Hopital Beaujon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion criteria for the patients treated with antibiotics

• 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

Inclusion criteria for the patients in the reference group

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
A secondary endpoint is to describe the changes in the gut microbiota of hospitalized patients not receiving antibiotics.	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Victoire De Latours, Doctor, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Fluoroquinolones; Study of commensal flora
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: RAFREU53