Antimicrobial ResistanceE-FLUENTNCT07234331
A Multicentre Study of Wastewater and Antibiotic Resistance in Care Homes.
An observational study of Antimicrobial Resistance, run by Nantes University Hospital at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antimicrobial Resistance
- How many people
- 1,600 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Mar 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nursing home residents located in Loire-Atlantique and Maine-et-Loire, France
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU d'Angers
Angers, 49100
Clément Legeay, PH, 02 41 35 59 34, Clement.legeay@chu-angers.fr
- Recruiting
CHU de Nantes
Nantes, 44093
Gabriel Birgand, PH, 02.40.08.39.86, gabriel.birgand@chu-nantes.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Antimicrobial Resistance
- Keywords
- Nursing home, Wastewater, Surveillance
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive performance
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.
Measured: 15 months
Secondary outcomes (1)
Epidemiology of ESBL/CPE in nursing homes
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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start16 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial ResistanceStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234331
- Sponsor's protocol ID
- RC24_0586
- Acronym
- E-FLUENT
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Study Analysing Wastewater to Monitor Bacterial Resistance to Antibiotics in Residential Care Homes for Elderly Dependent.
- ClinicalTrials.gov ID
- NCT07234331
- Acronym / sponsor ID
- E-FLUENT / RC24_0586
- Conditions
- Antimicrobial Resistance
- Keywords
- Nursing home, Wastewater, Surveillance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nursing home residents located in Loire-Atlantique and Maine-et-Loire, France
Key inclusion criteria (8 listed)
- 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.);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Epidemiology of ESBL/CPE in nursing homes
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antimicrobial Resistance, run by Nantes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.