Multicentre Study Analysing Wastewater to Monitor Bacterial Resistance to Antibiotics in Residential Care Homes for Elderly Dependent.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- Predictive performance
研究概览
简要总结
This study aims to model the relationship between the prevalence of ESBL-E and CPE carriage among nursing home residents and their respective concentrations in wastewater discharged from the facility.
详细描述
Extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-PE) are now endemic in France, complicating the management of infections. In parallel, carbapenemase-producing Enterobacterales (CPE) are exhibiting rapid growth, necessitating enhanced surveillance systems and preventive measures across the healthcare network.
Current antimicrobial resistance (AMR) surveillance systems, which rely primarily on clinical samples, underestimate the dissemination of commensal bacteria and therefore limit the ability to anticipate epidemic events.
Transmission of ESBL-PE and CPE has been documented in long-term care facilities (LTCFs), where they may play a significant role in amplifying and maintaining outbreaks within the healthcare network. However, no dedicated surveillance system currently exists in these facilities.
The current French national strategy is based on standard precautions, but improved detection and identification of ESBL-PE and CPE in LTCFs could enable more effective prevention of transmission and reduce control-related costs.
The primary objective of this study is to model the relationship between the prevalence of ESBL-PE and CPE carriage among LTCF residents and their respective concentrations in facility wastewater effluents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residents present on the day of sampling (D0 or D+1) in a facility selected during randomization, without criteria regarding length of stay in the facility, and whose health status on the day of the survey permits it;
- •Residents who, based on clinical criteria (including an MMSE greater than or equal to 20), are deemed by the nursing home team to be able to understand the issues of the study and to express an informed non-opposition; OR Residents who the nursing home team considers unable to express an informed non-objection but who have a legal representative, a trusted person, or a loved one capable of understanding the information and expressing an informed non-objection.
- •Residents may be included regardless of the presence of infection, diarrheal stools, antibiotic use or any other treatment, or health status.
- •Participants in this study may participate in other research projects concurrently.
排除标准
- •Health and medico-social facilities not considered nursing homes (e.g., FAM, MAS, etc.);
- •Residents whose health status is incompatible with performing the procedure on the day of the survey (e.g., end-of-life with comfort care);
- •Residents with a Mini Mental State Examination (MMSE) score of less than or equal to 20, or without an MMSE score but who, according to nursing home professionals, are unable to provide an informed non-objection and who do not have a legal representative, trusted person, or relative capable of receiving information and providing an informed non-objection;
- •Residents, regardless of their MMSE score, who refuse to have the sample taken on the day of the survey even if their legal repre
结局指标
主要结局
Predictive performance
时间窗: 15 months
The primary endpoint will be the adequacy and predictive performance of the model for estimating the prevalence of ESBL-E/CPE carriage among nursing home residents. Carriage prevalence will be measured by collecting stool samples from residents or, failing that, by anorectal swabs.
次要结局
- Epidemiology of ESBL/CPE in nursing homes(15 months)