A Multicentre Study of Wastewater and Antibiotic Resistance in Care Homes. (E-FLUENT)

April 13, 2026 updated by: Nantes University Hospital

Multicentre Study Analysing Wastewater to Monitor Bacterial Resistance to Antibiotics in Residential Care Homes for Elderly Dependent.

This study aims to model the relationship between the prevalence of ESBL-E and CPE carriage among nursing home residents and their respective concentrations in wastewater discharged from the facility.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-PE) are now endemic in France, complicating the management of infections. In parallel, carbapenemase-producing Enterobacterales (CPE) are exhibiting rapid growth, necessitating enhanced surveillance systems and preventive measures across the healthcare network.

Current antimicrobial resistance (AMR) surveillance systems, which rely primarily on clinical samples, underestimate the dissemination of commensal bacteria and therefore limit the ability to anticipate epidemic events.

Transmission of ESBL-PE and CPE has been documented in long-term care facilities (LTCFs), where they may play a significant role in amplifying and maintaining outbreaks within the healthcare network. However, no dedicated surveillance system currently exists in these facilities.

The current French national strategy is based on standard precautions, but improved detection and identification of ESBL-PE and CPE in LTCFs could enable more effective prevention of transmission and reduce control-related costs.

The primary objective of this study is to model the relationship between the prevalence of ESBL-PE and CPE carriage among LTCF residents and their respective concentrations in facility wastewater effluents.

The primary outcome measure will be the fit and predictive performance of the model for estimating the prevalence of ESBL-PE/CPE carriage among LTCF residents. Carriage prevalence will be assessed through stool sampling or, when unavailable, rectal swabbing. The explanatory variable will be the quantification of ESBL-PE/CPE or resistance genes in wastewater effluents discharged from the LTCF during the corresponding study period.

Study Type

Observational

Enrollment (Estimated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Nursing home residents located in Loire-Atlantique and Maine-et-Loire, France

Description

Inclusion Criteria:

  • Residents present on the day of sampling (D0 or D+1) in a facility selected during randomization, without criteria regarding length of stay in the facility, and whose health status on the day of the survey permits it;
  • Residents who, based on clinical criteria (including an MMSE greater than or equal to 20), are deemed by the nursing home team to be able to understand the issues of the study and to express an informed non-opposition; OR Residents who the nursing home team considers unable to express an informed non-objection but who have a legal representative, a trusted person, or a loved one capable of understanding the information and expressing an informed non-objection.

Residents may be included regardless of the presence of infection, diarrheal stools, antibiotic use or any other treatment, or health status.

Participants in this study may participate in other research projects concurrently.

Exclusion Criteria: Health and medico-social facilities not considered nursing homes (e.g., FAM, MAS, etc.);

  • Residents whose health status is incompatible with performing the procedure on the day of the survey (e.g., end-of-life with comfort care);
  • Residents with a Mini Mental State Examination (MMSE) score of less than or equal to 20, or without an MMSE score but who, according to nursing home professionals, are unable to provide an informed non-objection and who do not have a legal representative, trusted person, or relative capable of receiving information and providing an informed non-objection;
  • Residents, regardless of their MMSE score, who refuse to have the sample taken on the day of the survey even if their legal repre

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive performance
Time Frame: 15 months
The primary endpoint will be the adequacy and predictive performance of the model for estimating the prevalence of ESBL-E/CPE carriage among nursing home residents. Carriage prevalence will be measured by collecting stool samples from residents or, failing that, by anorectal swabs.
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiology of ESBL/CPE in nursing homes
Time Frame: 15 months

To assess the prevalence of residents carrying ESBL and CPE in the population of nursing home residents in Loire-Atlantique and Maine-et-Loire

  • Model the relationship between infected residents, ESBL carriers on the one hand, and CPE on the other, and the concentration in wastewater
  • To analyze the factors associated with the prevalence of EBLSE and CPE
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC24_0586

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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