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
18 Years
95 Years
Both
Candidemia
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 Center | Houston, Texas 77030-4096 |
| University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Henry Ford Health System | Detroit, Michigan 48202 |
| University of Texas Health Science Center | San Antonio, Texas 78284 |
| University of Houston College Of Pharmacy | Houston, Texas 77030 |
| University of Arkansas Medical Center | Little Rock, Arkansas 72205 |
