OBSERVER - a new infection diagnostic
Research type
Research Study
Full title
A multi-center, prOspective, validation study to assess the accuracy of a host-response Based diagnoStic for distinguishing bEtween bacteRial and Viral etiology in adult patiEnts with lower Respiratory tract infections
IRAS ID
224044
Contact name
John R Hurst
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study tests the ability of a new diagnostic blood test (ImmunoXpert™) to differentiate bacterial from viral infection in adults presenting to Emergency Departments and Community Clinics with fever and symptoms of a lower respiratory tract infection. The performance of the test will be compared against a gold standard 'expert' diagnosis, based on all the available clinical data. Parallel studies are being carried out in the UK, Germany and Israel. In total, we will study 1135 subjects. The study is important because new, rapid diagnostics can prevent unnecessary exposure to antibiotics that result in bacterial resistance, and speed the appropriate use of antibiotics in those who need them.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0251
Date of REC Opinion
4 May 2017
REC opinion
Favourable Opinion