Clinical trial NCT02031588: Impact of Ceftriaxone and/or Fluoroquinolone (FQ) Treatment on the Gut Microbiota of Hospitalized Patients.
Official title: Impact of Ceftriaxone and/or Fluoroquinolone (FQ) Treatment on the Gut Microbiota of Hospitalized Patients.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bacterial Infections
Keywords: Study of commensal flora
Fluoroquinolones
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: A secondary endpoint is to describe the changes in the gut microbiota of hospitalized patients not receiving antibiotics.
timeFrame: 1 year
Other outcomes:
Locations:
city: Clichy la garenne
country: France
facility: Hôpital Beaujon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Victoire De Latours, Doctor
role: PRINCIPAL_INVESTIGATOR
References: