MedTrace Logo

T2Bacteria Panel Pivotal Study

NCT02535468 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2430

Last updated 2018-08-17

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood "clinical samples".

Conditions

  • Bacteremia

Sponsors & Collaborators

  • T2 Biosystems

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-04-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02535468 on ClinicalTrials.gov