Clinical trial NCT01752166: Detecting Infections Rapidly and Easily for Candidemia Trial - Part 2 (direcT2 Study)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidemia
Keywords: Candida
Candidemia
Blood culture
Diagnostics
Lead sponsor: T2 Biosystems
Sponsor class: INDUSTRY
First posted: 2012-12-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who have had a blood culture ordered, per routine standard of care

Brief summary: 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.

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 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.

Primary outcomes:
measure: Specificity
timeFrame: Up to 19 hours post blood collection
measure: Sensitivity
timeFrame: Up to 19 hours post blood collection
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Houston College of Pharmacy
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Alabama at Birmingham
name: Peter Pappas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mylonakis E, Clancy CJ, Ostrosky-Zeichner L, Garey KW, Alangaden GJ, Vazquez JA, Groeger JS, Judson MA, Vinagre YM, Heard SO, Zervou FN, Zacharioudakis IM, Kontoyiannis DP, Pappas PG. T2 magnetic resonance assay for the rapid diagnosis of candidemia in whole blood: a clinical trial. Clin Infect Dis. 2015 Mar 15;60(6):892-9. doi: 10.1093/cid/ciu959. Epub 2015 Jan 12.