NCT07234331

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Mar 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 16, 2026

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 14, 2025

Last Update Submit

April 13, 2026

Conditions

Keywords

Nursing homeWastewaterSurveillance

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 months

Secondary Outcomes (1)

  • Epidemiology of ESBL/CPE in nursing homes

    15 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU d'Angers

Angers, 49100, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

March 16, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

April 16, 2026

Record last verified: 2025-11

Locations