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Trial record 27 of 3448 for:    Facility

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

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ClinicalTrials.gov Identifier: NCT03477084
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborators:
Hospital Universitario Virgen Macarena
University Hospital Tuebingen
University Hospital, Geneva
UMC Utrecht
University of Oxford
Information provided by (Responsible Party):
Didier HOCQUET, Centre Hospitalier Universitaire de Besancon

Brief 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.

Condition or disease Intervention/treatment
Resistance Bacterial Enterobacteriaceae Infections Biological: ESBL-producing enterobacteriaceae carriage

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Understanding and Modelling Reservoirs, Vehicles and Transmission of ESBL-producing Enterobacteriaceae in the Community and Long Term Care Facilities
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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).



Biospecimen Retention:   Samples Without DNA
Stool sample, environmental samples (wastewater, sinks, showers, food, toilets)


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477084


Locations
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France
University Hospital
Besançon, Bourgogne Franche-Comté, France, 25030
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Hospital Universitario Virgen Macarena
University Hospital Tuebingen
University Hospital, Geneva
UMC Utrecht
University of Oxford
Investigators
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Study Director: Elise Robert University Hospital of Besançon - France

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Responsible Party: Didier HOCQUET, Full Professor - Hospital Practitioner, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03477084     History of Changes
Other Study ID Numbers: MODERN
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections