Status:
COMPLETED
Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)
Lead Sponsor:
T2 Biosystems
Conditions:
Candidemia
Eligibility:
All Genders
18-95 years
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT01525095
Start Date
January 1 2012
End Date
March 1 2014
Last Update
June 9 2014
Active Locations (5)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
2
University of California San Francisco
San Francisco, California, United States, 94110
3
University of Kentucky
Lexington, Kentucky, United States, 40536-0298
4
Henry Ford Hospital
Detroit, Michigan, United States, 48202