Epidemiology of Fluoroquinolone Resistance in Human Commensal Flora in Patients Hospitalised in Medical Wards

Hospitalized Patients Clinical Trial

Official title:

Epidemiology and Risk Factors Study of the Carriage of Fluoroquinolone Resistant Bacteria in the Commensal Flora of Patients Hospitalised in Medical Wards

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520715
• Other study ID #: FQ/EPI
• Status: Completed
• Phase: N/A
• First received: July 11, 2007
• Last updated: June 22, 2015
• Start date: June 2007
• Est. completion date: December 2007

Study information

• Verified date: June 2015
• Source: Association Pour le Recherche en Infectiologie et en Médecine Interne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical CommitteeFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonization
• Hospitalized Patients
• Multi Drug Resistant Bacteria

Locations

Country	Name	City	State
France	Hôpital Beaujon	Clichy	Ile de France

Sponsors (2)

Lead Sponsor	Collaborator
Association Pour le Recherche en Infectiologie et en Médecine Interne	Pr Bruno Fantin

Country where clinical trial is conducted

France,