NCT03248999

Brief Summary

This study evaluates individual and collective factors of ESBL and CRE carriage in nursing homes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 2, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 20, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2018

Completed
Last Updated

December 6, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

August 2, 2017

Last Update Submit

December 5, 2018

Conditions

Drug Resistance, Bacterial

Keywords

multidrug resistancenursing homeESBLCRE

Outcome Measures

Primary Outcomes (1)

  • ESBL and CRE carriage

    number of residents colonized with a extented-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE)

    the day of the study

Secondary Outcomes (1)

  • patient and establishment factors associated with ESBL and CRE carriage with a questionnaire

    the day of the study

Study Arms (1)

Experimental

EXPERIMENTAL

realization of a rectal swab or stool sample for all the résidents included in the study.

Diagnostic Test: rectal swab

Interventions

rectal swabDIAGNOSTIC_TEST

stool samples by rectal swab

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • voluntary residents present in the institution on the study day

You may not qualify if:

  • dement-wandering resident
  • unlikely to cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

Study Officials

  • Céline C Bouvier-Slekovec, Dr

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 15, 2017

Study Start

November 20, 2017

Primary Completion

June 26, 2018

Study Completion

June 26, 2018

Last Updated

December 6, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)