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Emergence of Fluoroquinolone Resistance in Commensal Flora (FQEMERG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01209247
First received: September 24, 2010
Last updated: August 25, 2014
Last verified: August 2014

September 24, 2010
August 25, 2014
October 2010
October 2012   (final data collection date for primary outcome measure)
emergence of fluoroquinolone-resistance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
To know the incidence and describe risk-factors involved in the emergence of fluoroquinolone-resistance in the commensal flora of patients treated by a fluoroquinolone.
Same as current
Complete list of historical versions of study NCT01209247 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Emergence of Fluoroquinolone Resistance in Commensal Flora
Emergence of Fluoroquinolone Resistance in the Commensal Flora of Patients Receiving Fluoroquinolone Treatment.

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
All Types of Infections
Other: Nasal, rectal and pharyngeal swabs
Nasal, rectal and pharyngeal swabs were performed before, during, and one month after the end of FQ treatment.
Other Name: Nasal, rectal and pharyngeal swabs
  • Active Comparator: patient treated by fluoroquinolone
    patient treated by fluoroquinolone. Nasal, rectal and pharyngeal swabs
    Intervention: Other: Nasal, rectal and pharyngeal swabs
  • Placebo Comparator: patient not receiving FQ treatment
    reference group of patients not receiving FQ treatment, but hospitalized in the same wards at the same time
    Intervention: Other: Nasal, rectal and pharyngeal swabs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
571
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01209247
AOR09005
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: De Lastours Victoire Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP