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

N/ATerminatedNCT02031588

Assistance Publique - Hôpitaux de Paris77 enrolled

Overview

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

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

Conditions

Bacterial Infections

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Hôpital Beaujon

Clichy, France

Outcomes

Primary Outcomes

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).

Time frame: 1 year

Secondary Outcomes

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

Time frame: 1 year

Data from ClinicalTrials.gov

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