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

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: Completed
• Conditions: Enterobacteriaceae Infections; Resistance Bacterial
• Intervention / Treatment: Biological: ESBL-producing enterobacteriaceae carriage

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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)	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

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: University Hospital, Geneva; UMC Utrecht; University of Oxford; University Hospital Tuebingen; Hospital Universitario Virgen Macarena
• Investigators: Study Director: Elise Robert, University Hospital of Besançon - France

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections
• Other Study ID 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