NCT07663110

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. 1.Why do people carry, transmit or get infected with CPE?
  2. 2.If a faster test was used to look for CPE, would this be better at reducing patient spread in hospital?
  3. 3.Is a faster test also more cost effective?
  4. 4.Be tested by both the usual and faster test when they come into hospital by a swab on their bottom
  5. 5.Where they test positive for CPE they will be asked to answer some questions about their health

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,000

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Aug 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Mar 2028

First Submitted

Initial submission to the registry

June 9, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 9, 2026

Last Update Submit

June 16, 2026

Conditions

Carbapenem-Resistant EnterobacteriaceaeColonisation

Keywords

infection prevention and controlhealth economicsrapid molecular diagnosticscarbapenem-resistant EnterobacteralesCPEsCROsMDROshospital transmission

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Health economic outcomes of CPE colonisation, infection and screening approaches

    From enrolment to the end of the follow up period at 12 months

  • Laboratory measures of diagnostic comparison

    From enrolment to the end of the follow up period at 12 months

  • Epidemiological measures of CPE colonisation

    From enrolment to the end of the follow up period at 12 months

  • Qualitative measures including public, stakeholder understanding and acceptability

    24 months

  • Qualitative study on CPE perspectives through stakeholder interviews, public engagement and focused workshops

    24 months

  • +1 more secondary outcomes

Study Arms (1)

Rapid molecular screening

EXPERIMENTAL

During the study period all eligible patients will undergo the intervention

Diagnostic Test: Rapid molecular diagnostic test for CPE identification

Interventions

Rapid molecular diagnostic test for CPE identificationDIAGNOSTIC_TEST

Participants will undergo a rectal swab and undergo rapid molecular testing for CPE colonisation

Rapid molecular screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charing Cross Hospital

London, United Kingdom

Location

St Thomas' hospital

London, United Kingdom

Location

Study Officials

  • Jon Otter

    Guy's and St Thomas NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Governance and Integrity

CONTACT

020 7594 9832RGIT@imperial.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 23, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

GB(2)