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Starting soon Observational

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

NCT07499505 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-04-15
Last updated
2026-03-30

Condition(s) studied

Multidrug-resistant Organisms (MDROs)

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Presence of genes encoding ESBLs and carbapenemases — 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) — 12 months
    Presence of plasmid replicons (incompatibility groups) in patients and in wastewater
  • Presence of the different bacterial populations — 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)

Trial sites (1)

FacilityCityRegionStatus
Hôpital Bichat-Claude Bernard Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07499505 on ClinicalTrials.gov ↗ ← All trials in France