SepTec BSI Study
Research type
Research Study
Full title
Clinical Feasibility Study of a Prototype Device System (SepTec) for Early Detection of Sepsis in Critically Ill Patients
IRAS ID
355113
Contact name
Iain J McCullagh
Contact email
Sponsor organisation
Novus Diagnostics Ltd
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
The SepTec BSI Study will evaluate the accuracy of a new test for bacteria and fungi in the bloodstream. Bacteria or fungus in the blood can lead to sepsis and patients can be very unwell and need to be treated with antibiotics urgently. At the moment, doctors need to use these medicines before they really know what is causing the infection. This can sometimes mean that the antibiotics picked are not the ones that would work the best, or they can lead to something called antimicrobial resistance were bugs get used to antibiotics and are not killed by them. The SepTec test is much quicker than the tests we have for bloodstream infections right now, and we hope that if the test works well enough, that doctors could use the information from it to pick the best antibiotics for their patients. We will recruit people who are intensive care, when their medical team believe that they might have a severe infection and are taking samples for the standard test, which is called a blood culture. We will take another blood sample while this is happening to use on the SepTec test. We will compare the results of the SepTec test to the results of the blood cultures.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0283
Date of REC Opinion
27 Oct 2025
REC opinion
Further Information Favourable Opinion