Fleming Initiative and Cepheid Launch Landmark TRACE-CPE Study to Evaluate Rapid Molecular Screening for Drug-Resistant Infections in NHS Hospitals
核心洞察
The Fleming Initiative (搜索) and Cepheid have launched TRACE-CPE, a 30-month real-world study at two major London NHS Trusts to evaluate rapid molecular screening for carbapenemase-producing Enterobacterales (搜索) (CPE).
The study compares rapid molecular diagnostics delivering results in approximately one hour against current culture-based screening that typically takes around 48 hours.
CPE is classified by the WHO as a critical-priority pathogen, and UKHSA data show acquired carbapenemase-producing organisms in England more than doubled between 2021 and 2023.
The Fleming Initiative (搜索), a partnership established by Imperial College London and Imperial College Healthcare NHS Trust, and Cepheid, a Danaher (搜索) company, today announced the launch of TRACE-CPE, a two-and-a-half-year research study designed to improve testing for antimicrobial resistance (AMR), one of the greatest global health challenges. The real-world study will evaluate how rapid molecular screening for carbapenemase-producing Enterobacterales (搜索) (CPE) can improve infection prevention and control, support effective use of NHS resources, protect patients, and help inform national screening policy.
The study will be conducted at two of the largest NHS Trusts in England: Imperial College Healthcare NHS Trust and Guy's and St Thomas' NHS Foundation Trust. The TRACE-CPE study is delivered through a partnership between the Fleming Initiative (搜索) and Cepheid, first announced in September 2024 at an event aligned with the UN General Assembly High-Level Meeting on AMR. Cepheid joined the Initiative as its first diagnostics partner, with a substantial, long-term commitment to collaborative scientific and clinical research as well as policy development and advocacy.
The Growing Threat of CPE
CPE represents one of the most urgent threats in the AMR crisis. The bacteria are resistant to most antibiotics, including carbapenems (搜索) used as a last-resort treatment for serious infections, and are classified by the World Health Organization (WHO) as a critical-priority pathogen. According to UK Health Security Agency (UKHSA) 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 it, and undetected spread inside hospitals can lead to outbreaks, longer stays, and higher mortality. Infectious outbreaks, particularly those involving CPE, carry significant financial consequences for NHS hospitals through ward and theatre closures and disruption to elective care. AMR kills over 1 million people around the world each year and is a growing challenge in treating leading infectious disease killers such as tuberculosis, Escherichia coli, and Methicillin-resistant Staphylococcus aureus (MRSA).
Study Design and Leadership
The research is led by Dr. 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, and Dr. Damien Ming, a research fellow at the Fleming Initiative (搜索) and an honorary consultant in infectious diseases at Imperial College Healthcare NHS Trust.
"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," said Dr. Jonathan Otter. "TRACE-CPE is the sort of cross-disciplinary collaboration the Fleming Initiative (搜索) was created to enable. 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 study compares rapid molecular CPE diagnostics, which can return a result in approximately one hour, against current culture-based screening, which typically takes around 48 hours. TRACE-CPE will test rapid CPE diagnostics in real-world NHS hospital settings to assess how faster results affect clinical practice, infection control, and hospital transmission. It will also study patient risk factors and colonisation patterns to understand how CPE spreads within hospitals, and assess costs, patient experience, and system-level impact to determine the value and feasibility of implementing rapid screening at scale.
Policy and System-Level Impact
Conducted over two and a half years, TRACE-CPE will draw on patient populations representative of the complexity and scale of acute care delivered by the NHS, providing a robust evidence base on how rapid molecular screening operates within frontline clinical workflows.
"Through our partnership with the Fleming Initiative (搜索), we are focused on generating the kind of evidence that determines whether diagnostics actually change outcomes inside the systems delivering care," said Anne Beaubrun, Vice President, Value and Access at Cepheid. "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 from TRACE-CPE are intended to provide policymakers, hospital leaders, and clinicians with the evidence base needed to determine how rapid CPE screening should be deployed across the NHS and comparable health systems facing the rising threat of drug-resistant infections. The Fleming Initiative (搜索) is supported by the UK government, as highlighted in the 10 Year Health Plan for England, and receives funding from industrial partners including GSK, LifeArc (搜索), and Cepheid.