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

NCT ID: NCT03477084

Last Updated: 2022-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Resistance Bacterial Enterobacteriaceae Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Long Term Care Facilities

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

ESBL-producing enterobacteriaceae carriage

Intervention Type BIOLOGICAL

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.

ESBL-producing enterobacteriaceae carriage

Intervention Type BIOLOGICAL

Carriage of ESBL-producing Escherichia coli or Klebsiella pneumoniae

Interventions

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ESBL-producing enterobacteriaceae carriage

Carriage of ESBL-producing Escherichia coli or Klebsiella pneumoniae

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Virgen Macarena

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elise Robert

Role: STUDY_DIRECTOR

University Hospital of Besançon - France

Locations

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University Hospital

Besançon, Bourgogne-Franche-Comté, France

Site Status

Countries

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France

Other Identifiers

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MODERN

Identifier Type: -

Identifier Source: org_study_id

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