Tackling Resistance And HealthCare Economics Through CPE Screening (TRACE-CPE)

Multi-centre Evaluation of Carbapenemase-producing Enterobacterales (CPE) Prevalence and Transmission Dynamics, Recommendations on Screening Strategies, and Health Economics Outcomes Research Impact to Inform Policy Change

The goal of this clinical study is to learn if it is possible to reduce the spread of resistant bacteria called CPEs (Carbapenemase producing Enterobacterales) between patients admitted to hospital.

CPEs can be carried in the gut of people without making them ill. Normally when patients come into hospital, they may undergo a swab test on their bottom to see if CPEs can be grown. This test can take up to 24 hours to produce a result.

The investigators want to use a faster test which takes 2 hours to produce a result, and whether this can make a difference to CPE spread between person to person.

The main questions it aims to answer are:

1. Why do people carry, transmit or get infected with CPE?
2. If a faster test was used to look for CPE, would this be better at reducing patient spread in hospital?
3. Is a faster test also more cost effective?

Participants will:

1. Be tested by both the usual and faster test when they come into hospital by a swab on their bottom
2. Where they test positive for CPE they will be asked to answer some questions about their health

Study Overview

• Status: Not yet recruiting
• Conditions: Carbapenem-Resistant Enterobacteriaceae; Colonisation
• Intervention / Treatment: Diagnostic test: Rapid molecular diagnostic test for CPE identification

Detailed Description

Carbapenemase-producing Enterobacterales (CPE) are a significant threat to healthcare through their ability to cause drug-resistant infections. These group of bacteria posses enzymes which break down and inactivate carbapenems, a broad spectrum class of antibiotics reserved for severe infections. Transmission of CPEs between patients occur through proximity / contact within their environment in hospital - and is therefore preventable.

Within the individual, initial colonisation with CPE is an important risk factor for development of multi-drug resistant infections which are associated with significant mortality and high hospital costs. The in-hospital transmission of CPE exerts a complex burden across almost all healthcare domains - for example, CPE infection or colonisation renders common surgical antibiotic prophylaxis ineffective, increases morbidity and mortality in vulnerable patient groups such as intensive care, places burdens on the use of single occupancy beds and imposes considerable cost and disruption to care pathways through outbreaks.

Existing microbiological diagnoses of CPEs vary, but commonly involve bacterial culture of a sample such as a rectal swab in laboratory settings followed by phenotypic testing and characterisation of common antibiotic resistant genes (ARGs) through molecular or immunochromatographic approaches, mostly focusing on the "big 5" mechanisms of CPE. Such testing pathways can however be time-consuming, with the median result turnaround time to be between 24-48 hours. Rapid molecular testing for CPE bypasses the bacterial culture step and may allow for robust IPC measures to be implemented in a near real-time fashion including rapid risk stratification of CPE carriage status. Where transmission is suspected, contact tracing using rapid testing early in the transmission cascade could reduce unwanted impact and be cost-effective.

The proposed study examines the utility, cost-benefit in adoption of a rapid based screening approach using rapid CPE testing coupled with an enhanced reporting workflow operating 24 hours a day, compared with existing standard practice. Given the complex interactions of AMR and CPE acquisition and transmission within hospital settings, a comprehensive approach including clinical, epidemiological and health economic costings will be utilised and modelled in order to accurately understand impact. Rapid CPE screening will be incorporated into clinical processes to minimise adverse impact and the research conducted as a pragmatic study.

The rapid test for use in this study is the Cepheid Xpert Carba-R which can detect genes in 5 most prevalent Carbapenemase gene families (including KPC, NDM, VIM, IMP and OXA classes) directly from a rectal swab sample in 50 minutes - this technology is CE-mark approved as an in vitro diagnostic and has undergone NICE technological appraisal

Research hypotheses to be addressed through the study:

1. The implementation of rapid molecular CPE detection through the Cepheid Xpert Carba-R with an enhanced reporting workflow is associated with greater effectiveness and timeliness in IPC interventions, compared with the existing use of culture-based screening strategies alone. This will lead to reductions in in-hospital transmission of CPE and result in downstream effects for organisation and individuals.
2. In-hospital screening strategies through rapid molecular CPE testing can be cost-effective from a health economic perspective and acceptable to patient and stakeholders, given particular clinical settings and baseline local CPE prevalence.

This is a multi-centre mixed methods research study consisting of:

1. A pragmatic prospective interventional interrupted time series study to examine impact of rapid Carbapenemase producing Enterobacterales (CPE) diagnostics and an enhanced reporting workflow in parallel with screening on clinical practice and transmission.
2. A clinical observational cohort study to characterise individual risk factors for CPE colonisation, epidemiology of colonisation including point-prevalence, and subsequent in-hospital transmission dynamics.
3. A health economic modelling study utilising hospital and national data to estimate medical costs, patient experience and systems level impact of screening, CPE colonisation and acquisition

The study will take place across two hospital Trusts:

i) Imperial College Healthcare NHS Trust (ICNHT), London ii) Guy's and St Thomas NHS Foundation Trust (GSTT), London

Project 1 will implement the Cepheid Xpert Carba-R rapid test in parallel to routine culture for CPE screening at two hospital sites to understand impact on IPC practice.

Project 2 will capture transmission dynamics, healthcare cost, patient acceptability and quality of life metrics using national datasets, and de-identified healthcare data collected from Project 1. Modelling using health economics outcome research methods will be performed to evaluate CPE screening strategies for a range of scenarios and settings with a view of informing policy. Health economic costings will utilise routinely available clinical data as well as costings metrics and health related grouping code from NHS Hospital Episode Statistics.

• Study Type: Interventional
• Enrollment (Estimated): 16000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Governance and Integrity; Phone Number: 020 7594 9832; Email: RGIT@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Charing Cross Hospital
    • Contact: Medicine & Integrated Care research office; Phone Number: +442033111234; Email: imperial.admin_trustresearchcontracts@nhs.net
  • London, United Kingdom
    • St Thomas' Hospital
    • Contact: R&D Governance team; Phone Number: +442071887188; Email: gstt.randd@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All adult (18 years or older) medical patients admitted to the acute medical unit during the implementation period who undergo routine rectal CPE testing as per local Trust policy and test positive for CPE colonisation through either the rapid test or culture-based methods.

Exclusion Criteria:

• Patient refusal for rectal screening or
• Clinical contraindication to rectal swab collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapid molecular screening; During the study period all eligible patients will undergo the intervention	Diagnostic test: Rapid molecular diagnostic test for CPE identification; Participants will undergo a rectal swab and undergo rapid molecular testing for CPE colonisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital secondary transmission of CPE colonisation	The primary outcome measure is the change in secondary in-hospital CPE transmission risk with the introduction of rapid rectal CPE screening. Quantification of transmission risk will be done using transmission dynamics modelling informed by collected clinical and epidemiological data.	From enrolment to the end of the follow up period at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health economic outcomes of CPE colonisation, infection and screening approaches	Direct, indirect and opportunity costs associated with CPE colonisation and infection using health economic cost analysis	From enrolment to the end of the follow up period at 12 months
Laboratory measures of diagnostic comparison	Concordance metrics between CPE rapid testing and culture including rate, genotype and species.	From enrolment to the end of the follow up period at 12 months
Epidemiological measures of CPE colonisation	Patient level risk factors for CPE acquisition, colonisation, and transmission.	From enrolment to the end of the follow up period at 12 months
Qualitative measures including public, stakeholder understanding and acceptability	Perspectives on CPE diagnostic implementation, patient and provider acceptability of CPE screening through stakeholder interviews, public engagement and workshops.	24 months
Qualitative study on CPE perspectives through stakeholder interviews, public engagement and focused workshops	This will be an adjunctive study with separate approvals process involving interviews with stakeholders to understand views and approaches to the management of CPE and detection. These findings will feed back into the main TRACE-CPE project.	24 months
Point prevalence of CPE	Prevalence of CPE colonisation derived from the number of positive CPE cases divided by the number of individuals undergoing screening.	Over the point prevalence period of 1 week

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Jon Otter, Guy's and St Thomas NHS Trust

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: health economics; carbapenem-resistant Enterobacterales; infection prevention and control; rapid molecular diagnostics; CPEs; CROs; MDROs; hospital transmission
• Other Study ID Numbers: 361309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data is recorded under the General Data Protection Regulation framework and will not be shared outside the research and clinical teams. Aggregated data will be presented and can be shared under such approvals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No