Evaluating a POC device for sepsis
Research type
Research Study
Full title
An evaluation of a novel point of care device for the detection of sepsis in patients admitted to hospital
IRAS ID
317628
Contact name
Ben Morton
Contact email
Sponsor organisation
Liverpool School of Tropical Medicine
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
Sepsis is a life-threatening illness caused by a dysregulated immune response to infection. There almost 50 million cases of sepsis per year globally and 11 million sepsis-associated deaths. Early antibiotics for sepsis can improve survival. Doctors, however, currently lack objective criteria on when to commence antibiotics; the choice of agent(s); and when to complete treatment for sepsis. This drives liberal administration of antimicrobials, exacerbating bacterial resistance against antibiotics and harms caused by the drugs themselves (such as severe diarrhoea). Project partners Frequasense Ltd and Liverpool University Hospital Foundation Trust (LUHFT), have developed a test that, in laboratory testing, can rapidly and accurately diagnose bacterial sepsis, from other causes of urgent acute illnesses. If this worked in clinical practice, a rapid and accurate sepsis diagnostic would empower clinicians to administer timely and appropriately antibiotics to patients with sepsis and to withhold potentially harmful antibiotics in patients without infection-related acute illness.
The aim of this study is to recruit adult patients (≥18 years of age) who present to the accident and emergency department with acute illness (including those with suspected sepsis and those without suspected sepsis) and to take a single blood sample. Those patients will then be followed up to determine their confirmed diagnosis (after clinical investigations and treatment are completed) and outcome (survival to 90 days after admisssion). Final follow up will be by telephone at 90 days. The blood sample will be used to test our device in the laboratory to validate previous studies of diagnostic accuracy. In parallel we will conduct interviews and focus group discussion with key stakeholders including patients, carers and health professionals to explore usefullness and ease of use of a prototype device. The devices and their readings will not be used to influence patient care at any point during this study.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
22/YH/0170
Date of REC Opinion
29 Sep 2022
REC opinion
Further Information Favourable Opinion