Tackling Resistance And HealthCare Economics Through CPE Screening
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient refusal for rectal screening or
Clinical contraindication to rectal swab collection
Trial design
Design model
Single group
Treatments tested in this trial
Rapid molecular diagnostic test for CPE identification
Diagnostic testParticipants will undergo a rectal swab and undergo rapid molecular testing for CPE colonisation
Treatment groups
16,000 Participants
are divided into 1 treatment groupGroup A: Rapid molecular screeningExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrolment to the end of the follow up period at 12 monthsSecondary outcomes
1
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
Time frame
From enrolment to the end of the follow up period at 12 months2
Laboratory measures of diagnostic comparison
Concordance metrics between CPE rapid testing and culture including rate, genotype and species.
Time frame
From enrolment to the end of the follow up period at 12 months3
Epidemiological measures of CPE colonisation
Patient level risk factors for CPE acquisition, colonisation, and transmission.
Time frame
From enrolment to the end of the follow up period at 12 months4
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.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov
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