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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


N/A
18 Years
95 Years
Not Enrolling
Both
Candidemia

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Specificity

Outcome Description:

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.

Outcome Time Frame:

Up to 19 hours post blood collection

Safety Issue:

No

Principal Investigator

Peter Pappas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

PRO-00031

NCT ID:

NCT01752166

Start Date:

April 2013

Completion Date:

September 2013

Related Keywords:

  • Candidemia
  • Candida
  • Candidemia
  • Blood culture
  • Diagnostics
  • Candidemia

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Henry Ford Health SystemDetroit, Michigan  48202
University of Texas Health Science CenterSan Antonio, Texas  78284
University of Houston College Of PharmacyHouston, Texas  77030
University of Arkansas Medical CenterLittle Rock, Arkansas  72205