NCT00520715

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

5 months

First QC Date

July 11, 2007

Last Update Submit

June 22, 2015

Conditions

Keywords

fluoroquinolone resistancecommensal floracarriage

Study Arms (1)

Patients at hospital admission

Patients at hospital admission in medical wards on our tertiray care hospital (Hôpital Beaujon, Clichy, France).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults patients at hospital admission hospital stay \>24 hours informed consent required

You may qualify if:

  • all adult patients admitted to the internal medicine, oncology, cardiology and geriatric unit of Beaujon Hospital, Clichy, France.
  • patient agreement

You may not qualify if:

  • Age \< 18
  • patient refusal or incapable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Beaujon

Clichy, Île-de-France Region, 92110, France

Location

Related Publications (1)

  • de Lastours V, Chau F, Tubach F, Pasquet B, Ruppe E, Fantin B. Independent behavior of commensal flora for carriage of fluoroquinolone-resistant bacteria in patients at admission. Antimicrob Agents Chemother. 2010 Dec;54(12):5193-200. doi: 10.1128/AAC.00823-10. Epub 2010 Sep 27.

Study Officials

  • Victoire de Lastours, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 11, 2007

First Posted

August 24, 2007

Study Start

June 1, 2007

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations