跳至主要内容
临床试验/NCT07499505
NCT07499505尚未招募不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
Presence of genes encoding ESBLs and carbapenemases

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Presence of genes encoding ESBLs and carbapenemases

时间窗: 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)

时间窗: 12 months

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

Presence of the different bacterial populations

时间窗: 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)

次要结局

  • 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(12 months)
  • Presence of resistance plasmids.(12 months)
  • Antibiotic intake at the time of the sampling campaign(12 months)
  • Concentrations of antibiotics in wastewater.(12 months)
  • Results obtained by the different methods of microbiological, genomic and metagenomic culture.(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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