Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT) (DIRECT)

June 6, 2014 updated by: T2 Biosystems

Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)-Part 1 (Prospective Collection and Freezing of Whole Blood Specimens)

The purpose of this study is to assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Candida Assay.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

700

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
    • California
      • San Francisco, California, United States, 94110
        • University of California San Francisco
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0298
        • University of Kentucky
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Texas
      • 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 undergone a diagnostic blood culture.

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. For Group A,

    • Males and females 18 - 95 years of age.
    • Subject is confirmed to have fungemia as evidenced by a positive diagnostic blood culture and subsequent species identification.

  3. For Group B,

    • Males and females 18 - 95 years of age.
    • Subject is hospitalized with a medical problem other than fungemia, or is being treated as an outpatient for some non-infection-related condition, and
    • Subject is confirmed to not have fungemia as evidenced by diagnostic blood culture and subsequent species identification.

Exclusion Criteria:

  1. Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
  2. 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.

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
Candida Positive Patients
Symptomatic adult patients, confirmed via concordant diagnostic blood culture and species identification and subsequent second blood culture results and species identification that are Candida positive
Candida Negative Patients
Hospitalized adult patients, confirmed via concordant diagnostic blood culture with subsequent species identification and subsequent second blood culture with subsequent species identification that are Candida negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Candida Positive patients
Time Frame: 3-5 days post blood culture
Number of Candida Positive patients based on concordant, sequential blood culture results and a positive T2 signal
3-5 days post blood culture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Candida Negative Patients
Time Frame: 3-5 days post blood culture
Number of Candida Negative patients based on concordant, sequential blood culture results and a negative T2 signal
3-5 days post blood culture

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

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria

February 1, 2012

First Posted (Estimate)

February 2, 2012

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 6, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-00030

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.

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