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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01525095
Other study ID # PRO-00030
Secondary ID
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


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
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