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Multidrug-resistant Organisms (MDROs)ROSEAUNCT07499505

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

An observational study of Multidrug-resistant Organisms (MDROs), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multidrug-resistant Organisms (MDROs)
How many people
150 participants
Where
1 siteFrance
Study dates
15 Apr 2026to 15 Apr 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: 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

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Laurence ARMAND-LEFEVRE, MD contact

01 40 25 85 00

laurence.armand@aphp.fr

Claire Hobson, MD contact

06 01 02 25 59

claire.hobson@aphp.fr

France1 site
  • Hôpital Bichat-Claude Bernard

    Paris, 75010

    Laurence Armand-Lefevre, MD, 01 40 25 85 00, laurence.armand@aphp.fr

    Claire Hobson, MD, claire.hobson@aphp.fr

Other trials in France

About this study

Official title: 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.

Read the 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.

Keywords
multidrug-resistant organisms (MDROs)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07499505
Study groupRoleWhat they receive
Patients hospitalized at the time of the campaign50 patients (45 in full hospitalization and 5 in day hospital) per campaign. There will be 3 inclusion campaigns: 150 patients in total

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 12 months

  2. Presence of plasmid replicons (incompatibility groups)

    Presence of plasmid replicons (incompatibility groups) in patients and in wastewater

    Measured: 12 months

  3. 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)

    Measured: 12 months

Secondary outcomes (7)
  1. 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

    Measured: 12 months

  2. Description of the different bacterial populations of BMR and consequently of antibiotic resistance genes, and mobile genetic elements (plasmids) in each sample over time

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. Antibiotic intake at the time of the sampling campaign

    The objective is to compare prescribing data and antibiotic dosages in the environment.

    Measured: 12 months

  6. Concentrations of antibiotics in wastewater.

    The objective is to compare prescribing data and antibiotic dosages in the environment.

    Measured: 12 months

  7. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start15 Apr 2026 (estimated)
  3. Primary completion15 Apr 2027 (estimated)
  4. Study completion15 Apr 2027 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07499505
Sponsor's protocol ID
APHP251214
Other IDs
2025-A01864-45
Acronym
ROSEAU
Status last verified
Mar 2026
First submitted
24 Mar 2026
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multidrug-resistant Organisms (MDROs), run by Assistance Publique - Hôpitaux de Paris at 1 site 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 5 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: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Laurence ARMAND-LEFEVRE, MD (01 40 25 85 00, laurence.armand@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of genes encoding ESBLs and carbapenemases (time frame: 12 months). The study lists 3 primary outcomes in all. 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 30 Mar 2026.

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