NCT02853708

Brief Summary

The sequence type 131 (ST131) is a predominant lineage among extraintestinal pathogenic Escherichia coli. It plays a major role in the worldwide dissemination of E. coli that produce extended-spectrum beta-lactamase (ESBL). The aim of this study was to describe the epidemiology of ESBL producing ST131clonal group in our university hospital. All patients with an infection due to ESBL E. coli will be prospectively included for a 2-year period. ST131 isolates will be identified and risk factors associated to ST131 will be determined in comparison to non-ST131 ESBL E. coli.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

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, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

1.6 years

First QC Date

July 19, 2016

Last Update Submit

October 16, 2017

Conditions

Keywords

E. coliextended-spectrum beta-lactamasemolecular epidemiologyrisk factors

Outcome Measures

Primary Outcomes (1)

  • Risk factors associated to ESBL ST 131 infections

    Time of hospitalization

    up to 2 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients hospitalized at CHRU Besançon and infected with ESBL producing E. coli

You may qualify if:

  • Patients infected with ESBL producing E. coli

You may not qualify if:

  • Patients known to be carrier or infected in the previous year, patients only colonised with ESBL producing E. coli.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire

Besançon, 25030, France

Location

Related Publications (4)

  • Nicolas-Chanoine MH, Bertrand X, Madec JY. Escherichia coli ST131, an intriguing clonal group. Clin Microbiol Rev. 2014 Jul;27(3):543-74. doi: 10.1128/CMR.00125-13.

    PMID: 24982321BACKGROUND
  • Lafolie J, Nicolas-Chanoine MH, Grenouillet F, Hocquet D, Bertrand X. Prevalence of Escherichia coli sequence type 131 and its H30 subclone among E. coli isolates in a French hospital. Int J Antimicrob Agents. 2014 Nov;44(5):466-8. doi: 10.1016/j.ijantimicag.2014.07.016. Epub 2014 Sep 3.

    PMID: 25241262BACKGROUND
  • Lafolie J, Sauget M, Cabrolier N, Hocquet D, Bertrand X. Detection of Escherichia coli sequence type 131 by matrix-assisted laser desorption ionization time-of-flight mass spectrometry: implications for infection control policies? J Hosp Infect. 2015 Jul;90(3):208-12. doi: 10.1016/j.jhin.2014.12.022. Epub 2015 Feb 28.

    PMID: 25799482BACKGROUND
  • Can F, Azap OK, Seref C, Ispir P, Arslan H, Ergonul O. Emerging Escherichia coli O25b/ST131 clone predicts treatment failure in urinary tract infections. Clin Infect Dis. 2015 Feb 15;60(4):523-7. doi: 10.1093/cid/ciu864. Epub 2014 Nov 6.

    PMID: 25378460BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacterial isolate

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

August 3, 2016

Study Start

June 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 17, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations