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Wastewater Surveillance for Carbapenem-Resistant Organism Outbreak Prediction in a Chinese Tertiary Hospital (WW-CRO-PREDICT)

2026年9月1日 更新者:Peking Union Medical College Hospital

Longitudinal Wastewater Monitoring of Antimicrobial Resistance Genes Across Functional Hospital Areas and Its Association With Clinical Carbapenem-Resistant Organism Infections: A Prospective Observational Cohort Study

Carbapenem-resistant organisms (CRO) pose a critical threat to global public health, and hospitals serve as major epicenters for their emergence and spread. Traditional clinical infection surveillance often detects CRO outbreaks only after infections have already occurred, missing the window for early intervention. Wastewater-based epidemiology has demonstrated its early warning potential during the COVID-19 pandemic and is increasingly recognized as a promising tool for antimicrobial resistance surveillance.

Our preliminary 22-day pilot study at Peking Union Medical College Hospital revealed two distinct antimicrobial resistance gene (ARG) dynamics patterns across different hospital areas: the Internal Medicine Ward exhibited a "chronic resistance background" with persistently high abundance of carbapenemase genes (IMP/GES types >5,000 ppm), while the Emergency/Fever Clinic showed "acute pulse outbreaks" characterized by transient 50- to 200-fold surges of mcr-3 and QnrVC genes. These findings suggest that hospital functional areas have fundamentally different ARG profiles with unique temporal signatures.

This prospective observational cohort study aims to establish a wastewater-based early warning system for hospital-acquired CRO outbreaks by conducting longitudinal monitoring across four key functional areas: Outpatient Building, Internal Medicine Ward, Surgical Ward, and Emergency/Fever Clinic at Peking Union Medical College Hospital over a 6- to 9-month period. Twenty-four-hour flow-proportional composite wastewater samples will be collected daily using automatic samplers. Laboratory analyses include ARG large-panel testing (300+ subtypes, daily), metagenomic sequencing (weekly, plus pulse-triggered intensified sampling), and viable bacterial culture with whole-genome sequencing of key isolates.

Concurrently, we will collect de-identified clinical CRO isolates and antibiotic consumption data (Defined Daily Doses) from the corresponding hospital buildings. Multidimensional association analyses will be performed using cross-correlation function analysis, Granger causality tests, and cgMLST-based genomic comparisons to determine the lead time of wastewater ARG signals ahead of clinical CRO diagnoses and to provide direct evidence of clonal homology between wastewater and clinical isolates. An early warning model will be constructed using dynamic thresholds (moving average + 2SD/3SD) and machine learning algorithms.

This study integrates environmental, clinical, and pharmaceutical data following the One Health framework. By establishing a replicable building-level wastewater resistome surveillance protocol, this research is expected to provide hospitals with a proactive tool for early CRO outbreak detection, enabling timely infection prevention and control measures. All clinical data will be de-identified, and the study has been designed to pose no greater than minimal risk to patients, with a waiver of informed consent sought in accordance with relevant ethical regulations.

研究概览

地位

尚未招聘

研究类型

观察性的

注册 (估计的)

720

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:yuda fei, Dr
  • 电话号码:+86 18501360830
  • 邮箱:fei_yuda@!63.com

学习地点

    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100730
        • Peking Union Medical College Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Environmental samples: 24-hour composite wastewater samples from 4 designated sewer manholes (Outpatient Building, Internal Medicine Ward, Surgical Ward, Emergency/Fever Clinic) at Peking Union Medical College Hospital.

Clinical data: De-identified CRO-positive culture results from patients treated in the above 4 hospital buildings during the study period.

描述

Inclusion Criteria:

  • Wastewater samples collected from the four designated sampling sites (Outpatient Building, Internal Medicine Ward, Surgical Ward, and Emergency/Fever Clinic).
  • 24-hour composite samples collected using automatic samplers following the flow-proportional mixing protocol.
  • Clinical data: Patients with laboratory-confirmed CRO infection (carbapenem-resistant Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii, etc.) from the above 4 hospital buildings during the study period.

Clinical data de-identified at the time of extraction.

Exclusion Criteria:

  • Wastewater samples from sites other than the four designated locations.
  • Samples contaminated or degraded during collection, transport, or storage.
  • Clinical data: CRO-positive results indicating colonization rather than infection.
  • Clinical data with incomplete key information (species, specimen source, date of detection, or department/location).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Outpatient Building
Community reference, non-hospitalized medical area
Internal Medicine Ward
Chronic high-resistance background area
Surgical Ward
Surgical prophylactic antibiotic use area
Emergency
Acute pulse outbreak sentinel area

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Wastewater Antimicrobial Resistance Gene (ARG) Abundance
大体时间:Daily for 6-9 months
Abundance of 300+ ARG subtypes (including carbapenemase genes blaIMP, blaGES, blaKPC, blaNDM, blaOXA; colistin resistance gene mcr-3; quinolone resistance gene QnrVC) measured in copies per million 16S rRNA reads (ppm) from 24-hour composite wastewater samples collected at 4 hospital sites
Daily for 6-9 months
Whole-Genome Sequences of Clinical CRO Isolates
大体时间:Clinical CRO isolates (50-80 selected strains) from each building during the study period
Clinical CRO isolates (50-80 selected strains) from each building during the study period are subjected to whole-genome sequencing (≥50× coverage). cgMLST typing, ARG annotation (AMRFinderPlus), and phylogenetic analysis are performed for clonal homology comparison with wastewater isolates.
Clinical CRO isolates (50-80 selected strains) from each building during the study period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:bin du, Dr、Peking Union Medical College Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年9月1日

首先提交符合 QC 标准的

2026年9月1日

首次发布 (实际的)

2026年9月4日

研究记录更新

最后更新发布 (实际的)

2026年9月4日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • PUMCH-WW-ARG-2026
  • 01050010 (其他赠款/资助编号:Peking Union Medical Foundation)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified metagenomic and whole-genome sequencing data will be submitted to NCBI Sequence Read Archive upon study completion, in accordance with journal requirements and data sharing policies

IPD 共享时间框架

upon study completion

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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