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ClinicalTrials.gov ID

NCT07663110

Lead Sponsor

Imperial College LondonOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

16,000Estimated

Last Update Posted

Jun 23, 2026Actual

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Nov 1, 2027Estimated

Completion Date

Mar 31, 2028Estimated

Official Title

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

Brief Summary

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

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.

• Carbapenem-Resistant Enterobacteriaceae
• Colonisation

• Rapid molecular diagnostic test for CPE identification

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Imperial College LondonOTHER

gstt.randd@nhs.net+442071887188