Detecting Infections Rapidly and Easily for Candidemia Trial - Part 2 (direcT2 Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
T2 Biosystems
ClinicalTrials.gov Identifier:
NCT01752166
First received: December 14, 2012
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to validate clinical performance (i.e. estimated sensitivity and specificity) of the T2 Candida test on the T2 DX Instrument compared to blood culture results and/or known Candida positive status of prospectively collected and contrived (i.e. Candida-spiked) clinical specimens.


Condition
Candidemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Collection and Testing of Un-Spiked and Candida-Spiked Fresh Whole Blood Specimens From Patients Who Have Been Referred For a Diagnostic Blood Culture

Further study details as provided by T2 Biosystems:

Primary Outcome Measures:
  • Specificity [ Time Frame: Up to 19 hours post blood collection ] [ Designated as safety issue: No ]
    Estimated specificity of the T2Candida test will be examined by comparing T2Candida test results from prospectively collected T2 clinical specimens to blood culture results from specimens that are culture negative for Candida and which have been collected at the same time and from the same anatomical location as the T2 specimens.

  • Sensitivity [ Time Frame: Up to 19 hours post blood collection ] [ Designated as safety issue: No ]
    Estimated sensitivity of the T2Candida test will be examined by comparing T2Candida test results to the known Candida positive status or Candida positive blood culture status of contrived specimens that have been spiked at clinically relevant concentrations of the target organisms and, where detected, to blood culture results from specimens that are culture positive for Candida and which have been collected at the same time and from the same anatomical location as the T2 specimens.


Biospecimen Retention:   Samples With DNA

Whole blood specimens


Estimated Enrollment: 1500
Study Start Date: July 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Blood culture
Subjects have had a blood culture ordered, per routine standard of care

Detailed Description:

This study will prospectively collect and analyze whole blood T2 clinical research specimens and concomitant blood culture specimens from patients who have been referred for a blood culture per routine standard of care. Additional analysis of blinded, contrived (i.e. Candida spiked and un-spiked whole blood) specimens will be completed by study sites to augment the analysis of Candida positive blood specimens prospectively obtained from the study population.

The clinical performance of the T2 Candida test on the T2 Dx Instrument will be evaluated by calculating the:

  • Estimated clinical specificity of the T2Candida test results compared to Candida negative blood culture results in prospectively collected specimens, and the
  • Estimated sensitivity of the T2 Candida test results compared to the known Candida positive status or Candida positive blood culture status of contrived specimens that have been spiked at clinically relevant concentrations of the target organisms and, where detected, to Candida positive blood culture results in prospectively collected clinical specimens.
  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 had a blood culture ordered, per routine standard of care

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. Subject has had a blood culture ordered, per routine standard of care.
  3. Subject is between 18-95 years of age

Exclusion Criteria:

  1. 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.
  2. Subject has had previous specimens tested by the T2Candida assay with valid results.
  3. Subject has had an anti-fungal drug administered through the same port or central line as is used to collect the clinical research specimens.
  4. Treatment of subject with any novel drug compound within 30 days prior to the collection of T2 blood specimens.
  5. T2 clinical specimen, Tube A contains <3ml of blood.
  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: NCT01752166

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030
University of Houston College of Pharmacy
Houston, Texas, United States, 77030
MD Anderson Cancer Center
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

Responsible Party: T2 Biosystems
ClinicalTrials.gov Identifier: NCT01752166     History of Changes
Other Study ID Numbers: PRO-00031
Study First Received: December 14, 2012
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by T2 Biosystems:
Candida
Candidemia
Blood culture
Diagnostics

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 August 18, 2014