Hospital Effluents: a Health Monitoring Tool in the Era of Multi-resistance (ROSEAU)

ROSEAU : Hospital Effluents: a Health Monitoring Tool in the Era of Multi-resistance

Bacterial antibiotic resistance (AMR) is at the heart of public health concerns, with multi- and highly antibiotic-resistant bacteria (MDRO) responsible for difficult-to-treat infections. These bacteria include extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) and carbapenemase-producing Enterobacteriaceae (EPC). One axis of the fight against AMR is the surveillance of the dissemination of MDROs, particularly in health facilities. This currently involves individual screening of patients, using a rectal swab, a method that has limitations in terms of cost and acceptability. In this context, wastewater monitoring has been proposed as a proxy for patient colonization, offering a simple-to-implement, ethically acceptable, inexpensive, and reproducible alternative. This approach could be particularly relevant in contexts where human sampling is difficult to carry out, such as nursing homes or prisons. It can also help identify the emergence of new resistance and evaluate the effectiveness of interventions by hospital hygiene teams.

A growing number of studies are looking at the role of effluents in the spread of multidrug-resistant bacteria, but this work is usually carried out on a large scale, covering entire hospitals or urban areas6. This approach, while relevant to a global vision, limits the ability to establish direct links between human colonization and environmental contamination.

The ROSEAU project takes advantage of the unique location of the Infectious and Tropical Diseases Building of Bichat Hospital, which benefits from an individual effluent network, thus providing an opportunity to establish a direct link between bacterial colonization of wastewater and that of patients. If such a correlation is demonstrated, resistance monitoring in wastewater could be a reliable proxy for human colonization, thus representing an alternative to individual sampling.

Study Overview

• Status: Not yet recruiting
• Conditions: Multidrug-resistant Organisms (MDROs)

Detailed Description

Bacterial antimicrobial resistance (AMR) is a major public health threat and surveillance is a key element in the fight against AMR. Of particular concern is the emergence and spread of multi- and highly antibiotic-resistant bacteria (MDROs), in particular extended-spectrum beta-lactamase (ESBL-E) and/or carbapenemase-producing Enterobacteriaceae (EPC). Indeed, the latter currently pose a major therapeutic challenge due to the ineffectiveness of almost all first-line antibiotics and the need, in the event of infection, to use second-line molecules. E-BLSE and EPC are Enterobacteriaceae that naturally colonize the gut microbiota of humans and animals, and whose abundance in the microbiota increases thanks to antibiotic treatments. These bacteria are released into wastewater via faecal excretions, contributing to their dissemination into the environment. It is now recognized that there are transfers of resistance between human and animal compartments and the environment, at the origin of the "One Health" concept.

To assess human colonization by MDRO, it is necessary to perform individual screenings either in the subjects' stool or by rectal swab. These samples are difficult to collect or may be perceived as uncomfortable by the subjects and raise ethical questions. In addition, their implementation is costly and time-consuming for both healthcare teams and laboratories, limiting their implementation to certain hospital units. Monitoring of MDROs in wastewater from various sources, such as homes or hospitals, has therefore been proposed as an intermediate (or proxy) marker of patient colonization that provides a simple-to-implement, ethically acceptable, and inexpensive alternative for monitoring these strains in a given environment. This method has been widely used during the COVID3 pandemic and is at the origin of national networks such as the Obépine network. However, current studies are mostly carried out at the scale of cities or entire hospitals and struggle to establish direct links between human colonization and environmental contamination. In addition, horizontal gene transfer, local bacterial multiplication and the presence of bacterial biofilms in pipes can modify the environmental composition of bacteria and resistance genes, and potentially create a bias in the estimation of human colonization. However, wastewater surveillance remains an interesting tool for monitoring the spread of bacterial resistance to antibiotics, helping to identify the emergence of new resistances and even evaluating the effectiveness of interventions by hospital hygiene teams.

The SMIT building has an independent wastewater network, inherited from the history of the Claude Bernard Hospital, which specialises in the management of infectious diseases. In addition, this department welcomes patients in whom the prevalence of MDRO carriage is much higher than the average of the general French population, thus reinforcing the epidemiological interest of this structure. This unique configuration provides an ideal framework to study the emergence and persistence of bacterial resistance, supported by the presence of antibiotics and biocides, which are widely used in this department. The analysis of the effluents from this building (environmental compartment) would not only make it possible to quantify and characterize the bacteria and their resistance genes released into the wastewater, but also to establish a direct link with the colonization of patients hospitalized in this pavilion.

The human population studied (human compartment) will be made up of adult patients hospitalized in the infectious and tropical diseases department (SMIT) of the Bichat - Claude-Bernard hospital at the time of a wastewater sampling campaign from the building.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Laurence Armand-Lefevre, MD; Phone Number: 01 40 25 85 00; Email: laurence.armand@aphp.fr
• Study Contact Backup: Name: Claire Hobson, MD; Phone Number: 06 01 02 25 59; Email: claire.hobson@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Hopital Bichat-Claude Bernard
    • Contact: Laurence Armand-Lefevre, MD; Phone Number: 01 40 25 85 00; Email: laurence.armand@aphp.fr
    • Contact: Claire Hobson, MD; Email: claire.hobson@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The human population studied (human compartment) will be made up of adult patients hospitalized in the infectious and tropical diseases department (SMIT) of the Bichat - Claude-Bernard hospital at the time of a wastewater sampling campaign from the building

Description

Inclusion criteria :

• Age≥ 18 years
• Hospitalized in the SMIT of the Bichat - Claude-Bernard hospital at the time of a wastewater sampling campaign from the building

Non inclusion criteria :

• Patient Objection of Data
• Patients under legal protection (curatorship, guardianship), safeguard of justice

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients hospitalized at the time of the campaign; 50 patients (45 in full hospitalization and 5 in day hospital) per campaign. There will be 3 inclusion campaigns: 150 patients in total

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of genes encoding ESBLs and carbapenemases	Presence of genes encoding ESBLs and carbapenemases in patients and in wastewater ESBLs (ESBL-encoding enzyme variants) carbapenemases (variants of NDM, OXA-48, VIM, IMP, KPC)	12 months
Presence of plasmid replicons (incompatibility groups)	Presence of plasmid replicons (incompatibility groups) in patients and in wastewater	12 months
Presence of the different bacterial populations	Presence of the different bacterial populations in patients and in wastewater (bacterial isolates characterized, after whole genome sequencing, by their Sequence Type, their MLST core genome and their complete genome)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity (CFU/ml) of the different bacterial populations of BMR and consequently of antibiotic resistance genes, and mobile genetic elements (plasmids) in each sample over time		12 months
Description of the different bacterial populations of BMR and consequently of antibiotic resistance genes, and mobile genetic elements (plasmids) in each sample over time		12 months
Presence of environmental bacteria carrying resistance genes	The objective is to identify the environmental reservoirs of resistance genes and the mobile genetic elements carrying these genes as well as the horizontal transfers of resistance determinants between MDROs and environmental bacteria.	12 months
Presence of resistance plasmids.	The objective is to identify the environmental reservoirs of resistance genes and the mobile genetic elements carrying these genes as well as the horizontal transfers of resistance determinants between MDROs and environmental bacteria.	12 months
Antibiotic intake at the time of the sampling campaign	The objective is to compare prescribing data and antibiotic dosages in the environment.	12 months
Concentrations of antibiotics in wastewater.	The objective is to compare prescribing data and antibiotic dosages in the environment.	12 months
Results obtained by the different methods of microbiological, genomic and metagenomic culture.	The objective is to compare wastewater test results (MDRO, resistance genes, and plasmids) according to the methods used to determine which are the most efficient for larger-scale surveillance.	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Laurence Armand-Lefevre, MD, Assistance Publique Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: multidrug-resistant organisms (MDROs)
• Other Study ID Numbers: APHP251214; 2025-A01864-45 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No