Detecting Infections Rapidly and Easily for Candidemia Trial - Part 2 (direcT2 Study)
This study is not yet open for participant recruitment.
Verified March 2013 by T2 Biosystems
Sponsor:
T2 Biosystems
Information provided by (Responsible Party):
T2 Biosystems
ClinicalTrials.gov Identifier:
NCT01752166
First received: December 14, 2012
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
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.
| Condition |
|---|
|
Candidemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 |
Further study details as provided by T2 Biosystems:
Primary Outcome Measures:
- Specificity [ Time Frame: Up to 19 hours post blood collection ] [ Designated as safety issue: No ]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.
- Sensitivity [ Time Frame: Up to 19 hours post blood collection ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Whole blood specimens
| Estimated Enrollment: | 1500 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Blood culture
Subjects have had a blood culture ordered, per routine standard of care
|
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| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adult patients who have had a blood culture ordered, per routine standard of care
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752166
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Not yet recruiting |
| Birmingham, Alabama, United States, 35294-0006 | |
| Contact: Beth Deerman 205-934-9662 jbeth@uab.edu | |
| Principal Investigator: Peter Pappas, MD | |
| United States, Arkansas | |
| University of Arkansas Medical Center | Not yet recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Naveen Sanath Kumar nsanathkumas@uams.edu | |
| Principal Investigator: Senu Apewokin, MD | |
| United States, Michigan | |
| Henry Ford Health System | Not yet recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Theresa Sheppard 313-916-2613 tsheppa1@hfhs.org | |
| Principal Investigator: Jose Vazquez, MD | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Diana Pakstis 412-648-6553 dlp5@pitt.edu | |
| Principal Investigator: Cornelius Clancy, MD | |
| United States, Texas | |
| University of Texas Health Science Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Lucrecia Salazar lucrecia.salazar@uth.tmc.edu | |
| Principal Investigator: Luis Ostrosky-Zeichner, MD | |
| University of Houston College of Pharmacy | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Nicholas Beyda, Pharm.D 713-795-8339 nbeyda@sleh.com | |
| Principal Investigator: Kevin Garey, Pharm.D. | |
| MD Anderson Cancer Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Lisa Marsh 713-563-9266 lymarsh@mdanderson.com | |
| Principal Investigator: Dimitrios Kontoyiannis, MD | |
Sponsors and Collaborators
T2 Biosystems
Investigators
| Principal Investigator: | Peter Pappas, MD | University of Alabama at Birmingham |
More Information
No publications provided
| Responsible Party: | T2 Biosystems |
| ClinicalTrials.gov Identifier: | NCT01752166 History of Changes |
| Other Study ID Numbers: | PRO-00031 |
| Study First Received: | December 14, 2012 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by T2 Biosystems:
|
Candida Candidemia Blood culture Diagnostics |
Additional relevant MeSH terms:
|
Candidemia Fungemia Sepsis Infection Candidiasis, Invasive |
Candidiasis Mycoses Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013