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.
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.
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
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.
- Conditions
- Multidrug-resistant Organisms (MDROs)
- 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 group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Presence of plasmid replicons (incompatibility groups)
Presence of plasmid replicons (incompatibility groups) in patients and in wastewater
Measured: 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)
Measured: 12 months
Secondary outcomes (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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 months
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
Concentrations of antibiotics in wastewater.
The objective is to compare prescribing data and antibiotic dosages in the environment.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidrug-resistant Organisms (MDROs)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Armand-Lefevre, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROSEAU : Hospital Effluents: a Health Monitoring Tool in the Era of Multi-resistance
- ClinicalTrials.gov ID
- NCT07499505
- Acronym / sponsor ID
- ROSEAU / APHP251214
- Conditions
- Multidrug-resistant Organisms (MDROs)
- Keywords
- multidrug-resistant organisms (MDROs)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 30 Mar 2026 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (5 listed)
- Age≥ 18 years
- Hospitalized in the SMIT of the Bichat - Claude-Bernard hospital at the time of a wastewater sampling campaign from the building
- Patient Objection of Data
- Patients under legal protection (curatorship, guardianship), safeguard of justice
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
Presence of genes encoding ESBLs and carbapenemases
Time frame: 12 months
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)
Presence of plasmid replicons (incompatibility groups)
Time frame: 12 months
Presence of plasmid replicons (incompatibility groups) in patients and in wastewater
Presence of the different bacterial populations
Time frame: 12 months
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)
7 secondary outcomes
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
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 30 Mar 2026.
- Individual participant dataSharing planned: No
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.
Laurence Armand-Lefevre, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
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.