NCT01752166

Detecting Infections Rapidly and Easily for Candidemia Trial - Part 2 (direcT2 Study)

Prospective Collection and Testing of Un-Spiked and Candida-Spiked Fresh Whole Blood Specimens From Patients Who Have Been Referred For a Diagnostic Blood Culture

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: T2 Biosystems · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to validate clinical performance (i.e. estimated sensitivity and specificity) of the T2 Candida test on the T2 DX Instrument compared to blood culture results and/or known Candida positive status of prospectively collected and contrived (i.e. Candida-spiked) clinical specimens.

Detailed description

This study will prospectively collect and analyze whole blood T2 clinical research specimens and concomitant blood culture specimens from patients who have been referred for a blood culture per routine standard of care. Additional analysis of blinded, contrived (i.e. Candida spiked and un-spiked whole blood) specimens will be completed by study sites to augment the analysis of Candida positive blood specimens prospectively obtained from the study population. The clinical performance of the T2 Candida test on the T2 Dx Instrument will be evaluated by calculating the: * Estimated clinical specificity of the T2Candida test results compared to Candida negative blood culture results in prospectively collected specimens, and the * Estimated sensitivity of the T2 Candida test results compared to the known Candida positive status or Candida positive blood culture status of contrived specimens that have been spiked at clinically relevant concentrations of the target organisms and, where detected, to Candida positive blood culture results in prospectively collected clinical specimens.

Conditions

• Candidemia

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-12-19
• Last updated: 2014-05-26

Locations

8 sites across 1 country: United States