Emergence of Fluoroquinolone Resistance in Commensal Flora

NCT ID: NCT01209247

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

571 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

All Types of Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patient treated by fluoroquinolone

patient treated by fluoroquinolone. Nasal, rectal and pharyngeal swabs

Group Type ACTIVE_COMPARATOR

Nasal, rectal and pharyngeal swabs

Intervention Type OTHER

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

patient not receiving FQ treatment

reference group of patients not receiving FQ treatment, but hospitalized in the same wards at the same time

Group Type PLACEBO_COMPARATOR

Nasal, rectal and pharyngeal swabs

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nasal, rectal and pharyngeal swabs

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

De Lastours Victoire

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

De Lastours Victoire

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

de Lastours V, Chau F, Roy C, Larroque B, Fantin B. Emergence of quinolone resistance in the microbiota of hospitalized patients treated or not with a fluoroquinolone. J Antimicrob Chemother. 2014 Dec;69(12):3393-400. doi: 10.1093/jac/dku283. Epub 2014 Jul 24.

Reference Type RESULT
PMID: 25063781 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ncbi.nlm.nih.gov/pubmed/25063781

Emergence of quinolone resistance in the microbiota of hospitalized patients treated or not with a fluoroquinolone.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AOR09005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cellulitis Optimal Antibiotic Treatment
NCT05584007 RECRUITING PHASE3