The 30-month research project will compare molecular screening against traditional culture methods to improve infection control and hospital resource management.
The Fleming Initiative and Cepheid launched TRACE-CPE, a 30-month research study designed to improve testing for antimicrobial resistance. The real-world study will evaluate how rapid molecular screening for carbapenemase-producing Enterobacterales (CPE) can improve infection prevention and control, support the use of National Health Service (NHS) resources, and help inform national screening policies.
The study is being conducted at two hospitals run by Imperial College Healthcare NHS Trust and Guy’s and St Thomas’ NHS Foundation Trust in England. Cepheid, a Danaher company, is the first diagnostics partner for the Fleming Initiative, which is a partnership between Imperial College London and Imperial College Healthcare NHS Trust.
CPE is classified by the World Health Organization as a critical-priority pathogen. It is a bacteria resistant to most antibiotics, including carbapenems, which are used as a last-resort treatment for serious infections. According to UK Health Security Agency surveillance data, reports of acquired carbapenemase-producing organisms in England more than doubled between 2021 and 2023.
Patients can carry CPE without symptoms while still transmitting the bacteria. Undetected spread in hospitals can lead to outbreaks, longer stays, and higher mortality rates. Outbreaks also carry financial consequences for hospitals through ward closures and disruption to elective care.
“Antimicrobial resistance will not be addressed effectively by awareness alone. It will be solved by evidence, translated into practice, in the places where antibiotic decisions are actually made,” says Jonathan Otter, director of infection prevention and control at Guy’s and St Thomas’ NHS Foundation Trust and principal investigator for the TRACE-CPE study, in a release. “Our aim is a future where CPE does not spread in our hospitals, and rapid, accurate testing is central to making that future real.”
The research compares rapid molecular CPE diagnostics, which can return a result in approximately one hour, against current culture-based screening that typically takes 48 hours. The study will test these diagnostics in hospital settings to observe how faster results affect clinical practice and hospital transmission.
Researchers will also study patient risk factors and colonization patterns to understand how CPE spreads within hospitals. The project aims to assess costs, patient experience, and system-level impact to determine the feasibility of implementing rapid screening at scale.
“TRACE-CPE extends beyond diagnostic performance to assess how rapid screening influences health system productivity, transmission dynamics, and patient outcomes,” says Anne Beaubrun, vice president, value and access at Cepheid, in a release. “It evaluates how these tools integrate into clinical workflows and infection prevention practices, generating evidence to strengthen antimicrobial stewardship, support delivery of the National Action Plan, and support evidence-based, long-term policy development in accordance with the NHS 10-year plan.”
Findings from the study are intended to provide evidence for policymakers and hospital leaders to determine how rapid CPE screening should be deployed across the NHS and similar health systems facing drug-resistant infections.
