Novel methods for diagnosis of infection
Research type
Research Study
Full title
Improving diagnostic tests for sepsis and other infection and assessing the impact on patient management
IRAS ID
268670
Contact name
Nathaniel Storey
Contact email
Sponsor organisation
Great Ormond Street Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
18HLT03, EMPIR / EUROMET
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Sepsis affects ~30 million people a year causing 6 million deaths worldwide, more than bowel, breast and prostate cancer combined. Sepsis is the life-threatening condition that arises when the body’s immune system over reacts to an infection potentially resulting in multi-organ dysfunction or failure.Sepsis must be detected and treated within hours if high mortality is to be avoided. Yet today there are a
lack of fast tests to diagnose and manage the condition. With each hour of delayed treatment associated with an additional 4% risk of death.Medical staff currently rely on numerous non-specific clinical signs to predict patient condition. Confusion associated with the accuracy and reproducibility of potential diagnostic solutions has led to variable hospital uptake. The main method for microbiological identification, blood culture, is simply not fast enough to guide initial sepsis treatment forcing physicians to guess which antibiotic to administer.
Next generation diagnostic methodologies could deliver innovative, fast, near
patient solutions to aid sepsis management. Yet they require support for robust
evaluation to ensure they can meet regulatory needs and be rapidly translated to
impact today’s sepsis patient. The solutions to many of these diagnostic challenges lies in better application of measurement science. Whether through supporting the development of rapid near patient tests or establishing a metrological framework dedicated to ensuring diagnostic accuracy, measurement science could have a crucial role in advancing sepsis diagnosis.This clinically focused research aims to develop rapid and accurate diagnostic tests for sepsis and other serious infections and facilitate their translation and application to provide the information to improve patient management.REC name
HSC REC B
REC reference
19/NI/0186
Date of REC Opinion
24 Sep 2019
REC opinion
Favourable Opinion