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
  Purpose

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.


Condition
Candidemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)-Part 1 (Prospective Collection and Freezing of Whole Blood Specimens)

Resource links provided by NLM:


Further study details as provided by T2 Biosystems:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 700
Study Start Date: January 2012
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients who have undergone a diagnostic blood culture.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525095

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
United States, California
University of California San Francisco
San Francisco, California, United States, 94110
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536-0298
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Texas
University of Houston College of Pharmacy
Houston, Texas, United States, 77030
Sponsors and Collaborators
T2 Biosystems
Investigators
Principal Investigator: Peter Pappas, MD University of Alabama at Birmingham
  More Information

No publications provided by T2 Biosystems

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: T2 Biosystems
ClinicalTrials.gov Identifier: NCT01525095     History of Changes
Other Study ID Numbers: PRO-00030
Study First Received: January 25, 2012
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by T2 Biosystems:
Candida
Diagnostic Assay
Blood culture
Sepsis
T2 Magnetic Relaxation

Additional relevant MeSH terms:
Candidemia
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014