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CompletedNCT03477084MODERNUpdated Mar 10, 2022

Understanding and Modeling Reservoirs, Vehicles and Transmission of ESBL-producing Enterobacteriaceae in the Community and Long Term Care Facilities

An observational study in Resistance Bacterial and Enterobacteriaceae Infections, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2022-03-10.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Enterobacteriaceae Infections with a site in France — 3 open to participants now, 3 under way, 1 of them phase 3. Enterobacteriaceae Infections · France.

Started
2017
with 1 other
Observational
9 of 12
2 open now
Registered
4th of 12
by date
Lead sponsor
1 of 12
Centre Hospitalier Universitaire de Besancon

Among the 12 studies in Enterobacteriaceae Infections with a site in France, this one is one of 2 that started in 2017, is one of 9 observational ones, and was the 4th registered.

Enterobacteriaceae Infections

59 studies on the registry are indexed under Enterobacteriaceae Infections; 14 are open to participants now.

Browse Enterobacteriaceae Infections studies →

Open to participants now

3 of the 12 studies in Enterobacteriaceae Infections with a site in France are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 9 Enterobacteriaceae Infections studies recruiting now, 4 set no upper age limit and 2 stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Enterobacteriaceae Infections with a site in France, or all of them as a file.
02

Study summary

The continuing spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE) is among the most important problems in antimicrobial resistance. It is also a good model to investigate the epidemiological complexity of resistance in Enterobacteriaceae. Available data on the transmission determinants of ESBL-PE in community settings are scarce, methodologically limited and mostly based on single centre studies. A comprehensive investigation using present typing and modelling techniques is warranted to develop a sound quantitative understanding of the interactions involved. A consortium of investigators with diverse expertise from countries with high and low endemicity of ESBL-EP has been created. Transmission and persistence of ESBL-PE within households and long-term care facilities will be studied. Individual and group-level determinants for transmission and persistence will be quantified, together with other ecological variables including environmental, food and wastewater contamination. Advanced molecular typing techniques and state of the art analytical methods will be used. Data generated in this project will directly inform a suite of mathematical models which, in addition to encapsulating current understanding of the processes, will be used to explore the potential effectiveness of different interventions to control ESBL-PE spread. The expected outputs are a comprehensive characterisation of ESBL-PE transmission considering bacterial clones and mobile genetic elements, as well as individual and ecologic-level factors in different settings, to inform public health authorities about interventions that should be prioritised to control transmission of these organisms.

03

Conditions studied

  • Resistance Bacterial
  • Enterobacteriaceae Infections
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  • Residents of the Bellevaux LTCF (Besançon - France)
  • Patients discharged from the University Hospital of Besançon and carrying ESBL-E. coli or K. pneumoniae and their household members

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Residents of the Bellevaux LTCF (Besançon - France)
  • Patients discharged from the University Hospital of Besançon and carrying ESBL-E. coli or K. pneumoniae and their household members

Exclusion criteria

Exclusion Criteria:

  • Participation rejection
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Long Term Care Facilities

    Spread of ESBL-producing E. coli and K. pneumoniae among the residents of Long Term Care Facilities.

    Biological: ESBL-producing enterobacteriaceae carriage

  • Households

    Household transmission of ESBL-producing bacteria after hospital discharge of a patient carrying ESBL-producing E. coli or K. pneumoniae.

    Biological: ESBL-producing enterobacteriaceae carriage

Interventions

  • BiologicalESBL-producing enterobacteriaceae carriage

    Carriage of ESBL-producing Escherichia coli or Klebsiella pneumoniae

06

What researchers measure

Primary outcomes

  1. Transmission of ESBL-producing E. coli and K. pneumoniae (ESBL-E) in the community (LTCF residents and in households)

    We will assess * For the cohort 'LTCF': the number of LTCF residents contaminated with an ESBL-E from other residents or from the environment within 35 weeks. * For the cohort 'Household': the number of people (sharing household with a ESBL-E carrying patient which has been discharged from the hospital) contaminated with ESBL-E within 4 months. These two measurements will be aggregated to arrive at one reported value : the number of secondary cases from one index case (ratio).

    Time frame: For the cohort 'LTCF': 35 weeks ; For the cohort 'Household': 4 months

07

Study locations

1 site
  • University Hospital
    Besançon, Bourgogne Franche-Comté 25030, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2017 to primary completion in Jul 2019, 28 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2018
First posted
Mar 26, 2018
StartActual
Mar 1, 2017
Primary completionActual
Jul 1, 2019
CompletionActual
Feb 29, 2020
Last update
Mar 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03477084
Collaborators
Hospital Universitario Virgen Macarena, University Hospital Tuebingen, University Hospital, Geneva, UMC Utrecht, University of Oxford
Responsible party
Sponsor
First posted
Mar 26, 2018
Start date
Mar 1, 2017
Primary completion
Jul 1, 2019
Completion
Feb 29, 2020
Last update
Mar 10, 2022

Study contacts

Elise Robert
study director · University Hospital of Besançon - France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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