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Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
T2 Biosystems
ClinicalTrials.gov Identifier:
NCT01525095
First received: January 25, 2012
Last updated: June 6, 2014
Last verified: June 2014

January 25, 2012
June 6, 2014
January 2012
December 2013   (final data collection date for primary outcome measure)
Number of Candida Positive patients [ Time Frame: 3-5 days post blood culture ] [ Designated as safety issue: No ]
Number of Candida Positive patients based on concordant, sequential blood culture results and a positive T2 signal
Same as current
Complete list of historical versions of study NCT01525095 on ClinicalTrials.gov Archive Site
Number of Candida Negative Patients [ Time Frame: 3-5 days post blood culture ] [ Designated as safety issue: No ]
Number of Candida Negative patients based on concordant, sequential blood culture results and a negative T2 signal
Same as current
Not Provided
Not Provided
 
Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)
Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)-Part 1 (Prospective Collection and Freezing of Whole Blood Specimens)

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole Blood specimens, in addition to bacterial and fungal species isolates

Non-Probability Sample

Adult patients who have undergone a diagnostic blood culture.

Candidemia
Not Provided
  • 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
Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
March 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01525095
PRO-00030
No
T2 Biosystems
T2 Biosystems
Not Provided
Principal Investigator: Peter Pappas, MD University of Alabama at Birmingham
T2 Biosystems
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP