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

February 23, 2022 updated by: Centre Hospitalier Universitaire de Besancon

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bourgogne Franche-Comté
      • Besançon, Bourgogne Franche-Comté, France, 25030
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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:

  • Participation rejection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Carriage of ESBL-producing Escherichia coli or Klebsiella pneumoniae
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
Carriage of ESBL-producing Escherichia coli or Klebsiella pneumoniae

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Transmission of ESBL-producing E. coli and K. pneumoniae (ESBL-E) in the community (LTCF residents and in households)
Time Frame: For the cohort 'LTCF': 35 weeks ; For the cohort 'Household': 4 months

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).
For the cohort 'LTCF': 35 weeks ; For the cohort 'Household': 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Besancon

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Geneva
UMC Utrecht
University of Oxford
University Hospital Tuebingen
Hospital Universitario Virgen Macarena

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Elise Robert, University Hospital of Besançon - France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MODERN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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