Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)

Completed

Conditions studied: Candidemia

In brief

The purpose of this study is to assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Candida Assay.

Key facts

Study ID

NCT01525095

Run by

T2 Biosystems

People needed

700

Starts

2012-01-01

Expected to finish

2014-03-01

Last updated by the study team

2014-06-09

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.
• For Group A,
• Males and females 18 - 95 years of age.
• Subject is confirmed to have fungemia as evidenced by a positive diagnostic blood culture and subsequent species identification.
• For Group B,
• Males and females 18 - 95 years of age.
• Subject is hospitalized with a medical problem other than fungemia, or is being treated as an outpatient for some non-infection-related condition, and
• Subject is confirmed to not have fungemia as evidenced by diagnostic blood culture and subsequent species identification.

You may not qualify if…

• Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California San Francisco — San Francisco, California, United States
• University of Kentucky — Lexington, Kentucky, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Houston College of Pharmacy — Houston, Texas, United States

Full record on ClinicalTrials.gov

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