Clinical Trial: Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)-Part I (Prospective Collection and Freezing of Whole Blood Specimens)

Brief Summary: To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay.

Detailed Summary: This protocol is intended for use by external sites collecting clinical research specimens for T2 Biosystems' use in developing the T2Bacterial Assay. Specimens and information on patients' medical history, blood properties, medications, and blood culture history/results are required from the T2Bacterial Assay's target patient population (i.e., candidates for blood culture). Ideally, clinical specimens for use in developing the T2Bacterial Assay will be collected from negative blood culture, positive non-bacteria blood culture and positive bacteria blood culture patients.
Sponsor: T2 Biosystems

Current Primary Outcome: Number of bacteremia positive patients [ Time Frame: 3-5 days post blood culture ]

Number of bacteria positive patients based on concordant, sequential blood culture results and a positive T2 signal


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of bacteremia negative patients [ Time Frame: 3-5 Days post blood culture ]

Number of negative bacteremia samples based on concordant, sequential blood culture results and a negative T2 signal


Original Secondary Outcome: Same as current

Information By: T2 Biosystems

Dates:
Date Received: August 7, 2013
Date Started: August 2013
Date Completion:
Last Updated: September 25, 2015
Last Verified: September 2015