Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)

Completed

• Conditions: Candidemia

• Registration Number: NCT01525095
• Lead Sponsor: T2 Biosystems

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 Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-02
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-06
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. 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.

2. 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.

3. 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.

Exclusion Criteria

1. Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
2. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Candida Positive patients	3-5 days post blood culture	Number of Candida Positive patients based on concordant, sequential blood culture results and a positive T2 signal

Secondary Outcome Measures

Name	Time	Method
Number of Candida Negative Patients	3-5 days post blood culture	Number of Candida Negative patients based on concordant, sequential blood culture results and a negative T2 signal

Trial Locations

Locations (5)

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