T2Bacteria Panel Pivotal Study

Completed

Conditions studied: Bacteremia

In brief

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".

Key facts

Study ID

NCT02535468

Run by

T2 Biosystems

People needed

2430

Starts

2015-12-01

Expected to finish

2016-06-01

Last updated by the study team

2018-08-17

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject or subject's legally authorized representative (LAR) must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
• Subject has had a diagnostic blood culture ordered, per routine standard of care (prospective arm only).
• Subject is between 18-95 years of age.

You may not qualify if…

• Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
• Subject has had previous specimens tested by the T2Bacteria Panel with valid results.
• Treatment of subject with any investigational novel drug compound within 30 days prior to the collection of T2 specimens.

Where it is running

• Henry Ford Health System — Detroit, Michigan, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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