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

Completed

Conditions studied: Candidemia

In brief

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.

Key facts

Study ID

NCT01752166

Run by

T2 Biosystems

People needed

1500

Starts

2013-07-01

Expected to finish

2014-04-01

Last updated by the study team

2014-05-26

Who can join

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

You may qualify if…

• Subject or subject's authorized representative 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 blood culture ordered, per routine standard of care.
• 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 T2Candida assay with valid results.
• Subject has had an anti-fungal drug administered through the same port or central line as is used to collect the clinical research specimens.
• Treatment of subject with any novel drug compound within 30 days prior to the collection of T2 blood specimens.
• T2 clinical specimen, Tube A contains <3ml of blood.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Georgia Regents University — Augusta, Georgia, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University of Houston College of Pharmacy — Houston, Texas, United States
• University of Texas Health Science Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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