TEST-IT

 

 

Trial Acronym	TEST-IT
Clinical Area	Critical Care
Trial Title	Point Of Care Testing For Sepsis: A Diagnostic Accuracy Study
Trial Status	Analysis and Reporting
Trial Registration	http://www.isrctn.com/ISRCTN97997760

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• Recruitment

  Recruitment Target	4501
  Date Open to Recruitment	October 2016
  Recruitment	412
  Date Closed to Recruitment	February 2018

• Trial Design

  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

  Chief Investigator

  Dr Ronan McMullan, Belfast Health & Social Care Trust Prof Danny McAuley, Queen’s University Belfast d.f.mcauley@qub.ac.uk

• Sponsor & Funders

  Sponsors	Belfast Health and Social Care Trust
  Funder	Innovate UK