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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01525095
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
T2 Biosystems

Tracking Information
First Submitted Date January 25, 2012
First Posted Date February 2, 2012
Last Update Posted Date June 9, 2014
Study Start Date January 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2012)
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 Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 1, 2012)
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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)
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 Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole Blood specimens, in addition to bacterial and fungal species isolates
Sampling Method Non-Probability Sample
Study Population Adult patients who have undergone a diagnostic blood culture.
Condition Candidemia
Intervention Not Provided
Study Groups/Cohorts
  • Candida Positive Patients
    Symptomatic adult patients, confirmed via concordant diagnostic blood culture and species identification and subsequent second blood culture results and species identification that are Candida positive
  • Candida Negative Patients
    Hospitalized adult patients, confirmed via concordant diagnostic blood culture with subsequent species identification and subsequent second blood culture with subsequent species identification that are Candida negative
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: February 1, 2012)
700
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01525095
Other Study ID Numbers PRO-00030
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party T2 Biosystems
Study Sponsor T2 Biosystems
Collaborators Not Provided
Investigators
Principal Investigator: Peter Pappas, MD University of Alabama at Birmingham
PRS Account T2 Biosystems
Verification Date June 2014