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OpenTrials
Completed

NCT Number: NCT03477084

Understanding and Modeling 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Besançon, Bourgogne-Franche-Comté, 25030, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESBL-producing enterobacteriaceae carriage

Biological

Carriage of ESBL-producing Escherichia coli or Klebsiella pneumoniae

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Hospital Universitario Virgen Macarena
  • UMC Utrecht
  • University Hospital Tuebingen
  • University Hospital, Geneva
  • University of Oxford

Registry information

Official study title

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

Acronym: MODERN

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 26, 2018
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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