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

Candidemia Clinical Trial

— direcT2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752166
• Other study ID #: PRO-00031
• Status: Completed
• Phase: N/A
• First received: December 14, 2012
• Last updated: May 23, 2014
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: T2 Biosystems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Candidemia

Locations

Country	Name	City	State
United States	Georgia Regents University	Augusta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Henry Ford Health System	Detroit	Michigan
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Houston College of Pharmacy	Houston	Texas
United States	University of Texas Health Science Center	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
T2 Biosystems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No