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Emergence of Fluoroquinolone Resistance in Commensal Flora

Emergence of Fluoroquinolone Resistance in the Commensal Flora of Patients Receiving Fluoroquinolone Treatment.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01209247
Acronym
FQEMERG
Enrollment
571
Registered
2010-09-27
Start date
2010-10-31
Completion date
2012-12-31
Last updated
2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All Types of Infections

Keywords

Fluoroquinolone -resistance, Commensal flora, Emergence of resistance

Brief summary

The emergence of resistance to fluoroquinolone (FQ) 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 rectal, nasal and pharyngeal flora will be collected from hospitalized patients before receiving a FQ, at the end of the treatment and 1 month after the end of treatment. Clinical data will be collected. The incidence and risk-factors associated with the emergence of resistance to FQ will be assessed by comparing groups with and without resistance both at the end of treatment and 1 month later.

Detailed description

Population involved: Patients hospitalized (\>1day) in one of the two participating university hospitals and receiving a treatment by a fluoroquinolone (FQ) antibiotic. Number of centers : 2 (SAINT LOUIS and BEAUJON Hospitals, ASSISTANCE PUBLIQUE HOPITAUX DE PARIS, Paris, France). Expected number of patients : 720 Aim : To study the incidence and risk-factors involved in the emergence of resistance to FQ in the commensal flora during and after treatment by a FQ. Methods: Nasal, rectal and pharyngeal swabs were performed before, during, and one month after the end of FQ treatment. Microbiological analysis will focus on 3 target bacterial species: Escherichia coli from the faecal flora, alpha-haemolytic streptococci from the pharyngeal flora and non-coagulase staphylococci in the nasal flora. Patients carrying resistance at day 0 in all three flora will be excluded. The incidence and risk-factors of the emergence of resistance to FQ will be assessed at the end of treatment by FQ and 1 month after the end of treatment. Patients having resistant bacteria in their flora at the end and/or after treatment will be compared with those with no resistance. The same swabs will be collected from a reference group of patients not receiving FQ treatment, but hospitalized in the same wards at the same time as the case patients in order to eventually detect horizontal transmission of FQ-resistant strains in the hospital ward.

Interventions

OTHERNasal, rectal and pharyngeal swabs

Nasal, rectal and pharyngeal swabs were performed before, during, and one month after the end of FQ treatment.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hospitalisation \>24hours in one of the participating wards Treatment by a fluoroquinolone antibiotic.

Exclusion criteria

* Pregnancy or breast feeding Patients refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
emergence of fluoroquinolone-resistance4 monthsTo know the incidence and describe risk-factors involved in the emergence of fluoroquinolone-resistance in the commensal flora of patients treated by a fluoroquinolone.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026