Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)

Candidemia Clinical Trial

— DIRECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525095
• Other study ID #: PRO-00030
• Status: Completed
• Phase: N/A
• First received: January 25, 2012
• Last updated: June 6, 2014
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: T2 Biosystems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Candidemia

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Houston College of Pharmacy	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
T2 Biosystems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Candida Positive patients	Number of Candida Positive patients based on concordant, sequential blood culture results and a positive T2 signal	3-5 days post blood culture	No
Secondary	Number of Candida Negative Patients	Number of Candida Negative patients based on concordant, sequential blood culture results and a negative T2 signal	3-5 days post blood culture	No