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

May 23, 2014 updated by: T2 Biosystems

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0006
        • University of Alabama at Birmingham
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Regents University
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center
      • Houston, Texas, United States, 77030
        • University of Houston College of Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Blood culture
Subjects have had a blood culture ordered, per routine standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: Up to 19 hours post blood collection
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
Time Frame: Up to 19 hours post blood collection
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T2 Biosystems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

December 14, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (ESTIMATE)

December 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 26, 2014

Last Update Submitted That Met QC Criteria

May 23, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-00031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Candidemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe