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

Enterobacteriaceae Infections Clinical Trial

— MODERN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477084
• Other study ID #: MODERN
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: February 29, 2020

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 29, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Enterobacteriaceae Infections
• Resistance Bacterial

Intervention

Biological:
• ESBL-producing enterobacteriaceae carriage
Carriage of ESBL-producing Escherichia coli or Klebsiella pneumoniae

Locations

Country	Name	City	State
France	University Hospital	Besançon	Bourgogne Franche-Comté

Sponsors (6)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Hospital Universitario Virgen Macarena, UMC Utrecht, University Hospital Tuebingen, University Hospital, Geneva, University of Oxford

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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