Menu
Not yet recruiting NCT07499505

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

Observational Multidrug-resistant Organisms (MDROs)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multidrug-resistant Organisms (MDROs). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • Presence of genes encoding ESBLs and carbapenemases [Time frame: 12 months]
  • Presence of plasmid replicons (incompatibility groups) [Time frame: 12 months]
  • Presence of the different bacterial populations [Time frame: 12 months]
Secondary outcome measures (7)
  • 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 [Time frame: 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 [Time frame: 12 months]
  • Presence of environmental bacteria carrying resistance genes [Time frame: 12 months]
  • Presence of resistance plasmids. [Time frame: 12 months]
  • Antibiotic intake at the time of the sampling campaign [Time frame: 12 months]
  • Concentrations of antibiotics in wastewater. [Time frame: 12 months]
  • Results obtained by the different methods of microbiological, genomic and metagenomic culture. [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Hôpital Bichat-Claude Bernard — Paris

Identifiers

NCT: NCT07499505 · APHP251214 · 2025-A01864-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗