Drug Resistance, BacterialWW-CRO-PREDICTNCT07804433
Wastewater Surveillance for Carbapenem-Resistant Organism Outbreak Prediction in a Chinese Tertiary Hospital
An observational study of Drug Resistance, Bacterial and Carbapenems, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Resistance, Bacterial, Carbapenems, Wastewater
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
yuda fei, Dr, +86 18501360830, fei_yuda@163.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Drug Resistance, Bacterial, Carbapenems, Wastewater
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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wastewater Antimicrobial Resistance Gene (ARG) Abundance
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
Measured: Daily for 6-9 months
Whole-Genome Sequences of Clinical CRO Isolates
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.
Measured: Clinical CRO isolates (50-80 selected strains) from each building during the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug Resistance, BacterialStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- bin du, Dr, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804433
- Sponsor's protocol ID
- PUMCH-WW-ARG-2026
- Other IDs
- 01050010
- Acronym
- WW-CRO-PREDICT
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Liu X, Wong MKL, Zhang D, Chan DCL, Chan OSK, Chan GPL, Shum MH, Peng Y, Lai CKC, Cowling BJ, Zhang T, Fukuda K, Lam TT, Tun HM. Longitudinal monitoring reveals the emergence and spread of blaGES-5-harboring carbapenem-resistant Klebsiella quasipneumoniae in a Hong Kong hospital wastewater discharge line. Sci Total Environ. 2023 Dec 10;903:166255. doi: 10.1016/j.scitotenv.2023.166255. Epub 2023 Aug 11.
PubMed 37574056Hendriksen RS, Munk P, Njage P, van Bunnik B, McNally L, Lukjancenko O, Roder T, Nieuwenhuijse D, Pedersen SK, Kjeldgaard J, Kaas RS, Clausen PTLC, Vogt JK, Leekitcharoenphon P, van de Schans MGM, Zuidema T, de Roda Husman AM, Rasmussen S, Petersen B; Global Sewage Surveillance project consortium; Amid C, Cochrane G, Sicheritz-Ponten T, Schmitt H, Alvarez JRM, Aidara-Kane A, Pamp SJ, Lund O, Hald T, Woolhouse M, Koopmans MP, Vigre H, Petersen TN, Aarestrup FM. Global monitoring of antimicrobial resistance based on metagenomics analyses of urban sewage. Nat Commun. 2019 Mar 8;10(1):1124. doi: 10.1038/s41467-019-08853-3.
PubMed 30850636