Trial Acronym TEST-IT
Clinical Area Critical Care
Description Point Of Care Testing For Sepsis: A Diagnostic Accuracy Study
Status Analysis and Reporting
Date Opened to Recruitment October 2016
Target Recruitment 4501 Samples
Recruitment to date 412 (Completed)
Date Closed to Recruitment February 2018
No. of Sites > 25
Trial Design A prospective, observational, multi-centre blinded accuracy study of a novel diagnostic.
Study Aim To assess the diagnostic accuracy of the Randox point of care (POC) multiplex polymerase chain reaction (Multiplex PCR) test in critically ill patients with suspected sepsis.
The primary objective of this study is measurement of the sensitivity, specificity, positive predictive value and negative predictive value of this novel test, in comparison with conventional culture, in critically ill adults with suspected sepsis.
“The secondary objectives of this study are:
(i) to estimate the true cost per test for conventional blood culture and for multiplex PCR
(ii) to estimate the time to result for conventional blood culture and for multiplex PCR”
Chief Investigator Dr Ronan McMullan / Prof Danny McAuley
Sponsors Belfast Health and Social Care Trust
Funder Innovate UK
Links http://www.isrctn.com/ISRCTN97997760