The Fleming Initiative, a partnership between Imperial College London and Imperial College Healthcare National Health Service (NHS) Trust, and Cepheid, part of Danaher, have begun the TRACE-CPE, a two-and-a-half-year research study aimed at improving testing for antimicrobial resistance (AMR).
The study will be conducted at two hospitals run by Imperial College Healthcare NHS Trust and Guy’s and St Thomas’ NHS Foundation Trust, both major NHS institutions in England.
TRACE-CPE will investigate whether rapid molecular screening for carbapenemase-producing Enterobacterales (CPE) can enhance infection prevention efforts, optimise NHS resources, and contribute to future national screening policy.
CPE is a type of bacteria resistant to most antibiotics, including last-resort carbapenems, and classified by the World Health Organization (WHO) as a critical-priority pathogen.
According to the UK Health Security Agency surveillance, reports of carbapenemase-producing organisms in England more than doubled between 2021 and 2023.
The study aims to compare rapid molecular diagnostic tests, which can deliver results in an hour, with standard culture-based methods that typically take around 48 hours.
Researchers will test the impact of faster results on clinical practice and hospital infection transmission, examine patient risk factors and patterns of colonisation, and assess the costs, patient experience, and system-level effects of rapid screening.
Rapid diagnostics have been identified as key in preventing undetected spread, which can lead to hospital outbreaks, longer patient stays, increased mortality, and significant financial strain due to ward closures and disrupted care.
Guy’s and St Thomas’ NHS Foundation Trust infection prevention and control director Dr Jonathan Otter led the study, along with Fleming Initiative research fellow Dr Damien Ming.
The TRACE-CPE research draws on diverse patient populations to ensure findings are representative of the NHS acute care environment.
Cepheid value and access vice-president Anne Beaubrun said: “Through our partnership with the Fleming Initiative, we are focused on generating the kind of evidence that determines whether diagnostics actually change outcomes inside the systems delivering care.”
“TRACE-CPE extends beyond diagnostic performance to assess how rapid screening influences health system productivity, transmission dynamics, and patient outcomes.
“It evaluates how these tools integrate into clinical workflows and infection prevention practices, generating evidence to strengthen antimicrobial stewardship (AMS), support delivery of the National Action Plan (NAP), and support evidence-based, long-term policy development in accordance with the NHS 10-year plan.”
Findings will be used to inform policymakers, hospital leaders, and clinicians on the evidence required for future deployment of rapid CPE screening across the NHS and similar health systems.
Earlier this year, Cepheid received clearance from the US Food and Drug Administration for its Xpert GI Panel, a multiplex polymerase chain reaction gastrointestinal pathogen testing solution.
