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

NCT01752166 | Completed

• 1 other identifier: PRO-00031
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 8

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.

Conditions

Candidemia

Keywords

Candida; Candidemia; Blood culture; Diagnostics

Outcome Measures

Primary Outcomes (2)

• Specificity

  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.

  Up to 19 hours post blood collection

• Sensitivity

  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.

  Up to 19 hours post blood collection

Study Arms (1)

Blood culture

Subjects have had a blood culture ordered, per routine standard of care

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who have had a blood culture ordered, per routine standard of care

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• T2 Biosystems: lead

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0006, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Houston College of Pharmacy

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 25586686 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood specimens

MeSH Terms

Conditions

Candidemia; Torulopsis

Condition Hierarchy (Ancestors)

Candidiasis, Invasive; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Pappas, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 19, 2012
• Study Start: July 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 26, 2014

Record last verified: 2014-05

Locations

US (8)