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

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Bacterial Infections

Study type: Observational

Funder types: Other

Identifiers

NCT02031588

RAFREU53

Details and patient eligibility

About

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

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

77 participants in 4 patient groups

Ceftriaxone

Description:

Patients receiving a C3G (ceftriaxone) during the hospitalization.

Ceftriaxone + Fluoroquinolone

Description:

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

Fluoroquinolones

Description:

fluoroquinolones (levofloxacin, ofloxacin, moxifloxacin or ciprofloxacin).

Reference

Description:

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.