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

NCT03477084 | Completed

• 1 other identifier: MODERN
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Resistance Bacterial; Enterobacteriaceae Infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

ESBL-producing enterobacteriaceae carriage BIOLOGICAL

Carriage of ESBL-producing Escherichia coli or Klebsiella pneumoniae

Households; Long Term Care Facilities

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Participation rejection

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Hospital Universitario Virgen Macarena: collaborator
• University Hospital Tuebingen: collaborator
• University Hospital, Geneva: collaborator
• UMC Utrecht: collaborator
• University of Oxford: collaborator

Study Sites (1)

University Hospital

Besançon, Bourgogne-Franche-Comté, 25030, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool sample, environmental samples (wastewater, sinks, showers, food, toilets)

MeSH Terms

Conditions

Enterobacteriaceae Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Elise Robert

  University Hospital of Besançon - France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 26, 2018
• Study Start: March 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: February 29, 2020
• Last Updated: March 10, 2022

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)