Epidemiology of ST131 in Besançon University Hospital | NCT02853708

Studies
Epidemiology of ST131 in Besançon University Hospital

NCT02853708

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Oct 17, 2017Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Escherichia Coli Infections

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Jul 19, 2016

First Submission Date that Met QC Criteria

Jul 29, 2016

First Posted Date

Aug 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2017

Last Update Posted Date

Oct 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Risk factors associated to ESBL ST 131 infections	Time of hospitalization	up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients infected with ESBL producing E. coli

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Régional Universitaire		Besançon		25030	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24982321	Background	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.
25241262	Background	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.

ID	Term
D004756	Enterobacteriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses