- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00520715
Epidemiology of Fluoroquinolone Resistance in Human Commensal Flora in Patients Hospitalised in Medical Wards
June 22, 2015 updated by: Dr Victoire de Lastours, Association Pour le Recherche en Infectiologie et en Médecine Interne
Epidemiology and Risk Factors Study of the Carriage of Fluoroquinolone Resistant Bacteria in the Commensal Flora of Patients Hospitalised in Medical Wards
Emergence of bacterial resistance to antibiotics, which is a major public health issue, appears to involve predominantly commensal flora.
No data exists concerning risk factors for the carriage of fluoroquinolone resistant bacteria in the flora of hospitalised patients.
We will conduct a prospective open study including all unselected patients hospitalised in medical wards of one hospital.
Nasal, pharyngeal and rectal swabs will be performed upon admission as well as a review of potential risk factors, after patient's information and acceptance.
Resistance testing aiming 3 pathogens (Staphylococcus, Streptococcus and E. coli) will be performed on all specimens, and a case control study will compare risk factors from the resistant and non-resistant groups, for each pathogen.
A thousand patients should be included in a year's time.
This work could help understand risk factors involved in the carriage of fluoroquinolone resistant pathogens, potentially responsible for invasive infections and inter-patient transmission of resistance.
Limiting bacterial resistance and transmission is a goal that can be successfully undertaken only if resistance mechanisms, but also risk factors of acquiring resistant bacteria are better understood.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
640
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ile de France
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Clichy, Ile de France, France, 92110
- Hopital Beaujon
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adults patients at hospital admission hospital stay >24 hours informed consent required
Description
Inclusion Criteria:
- all adult patients admitted to the internal medicine, oncology, cardiology and geriatric unit of Beaujon Hospital, Clichy, France.
- patient agreement
Exclusion Criteria:
- Age < 18
- patient refusal or incapable
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients at hospital admission
Patients at hospital admission in medical wards on our tertiray care hospital (Hôpital Beaujon, Clichy, France).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Victoire de Lastours, MD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
July 11, 2007
First Submitted That Met QC Criteria
August 23, 2007
First Posted (Estimate)
August 24, 2007
Study Record Updates
Last Update Posted (Estimate)
June 23, 2015
Last Update Submitted That Met QC Criteria
June 22, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- FQ/EPI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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