Clinical Trial: Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)

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

Official Title: Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)-Part 1 (Prospective Collection and Freezing of Whole Blood Specimens)

Brief Summary: 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.

Detailed Summary:
Sponsor: T2 Biosystems

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

Number of Candida 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 Candida Negative Patients [ Time Frame: 3-5 days post blood culture ]

Number of Candida Negative patients 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: January 25, 2012
Date Started: January 2012
Date Completion:
Last Updated: June 6, 2014
Last Verified: June 2014