Detroit, Michigan 48202

  • Bacteremia

Purpose:

The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood "clinical samples".


Criteria:

Inclusion Criteria: - Subject or subject's legally authorized representative (LAR) 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 diagnostic blood culture ordered, per routine standard of care (prospective arm only). - 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 T2Bacteria Panel with valid results. - Treatment of subject with any investigational novel drug compound within 30 days prior to the collection of T2 specimens.


Study is Available At:


Original ID:

PRO-00400


NCT ID:

NCT02535468


Secondary ID:


Study Acronym:

T2Bacteria


Brief Title:

T2Bacteria Panel Pivotal Study


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

95 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

T2 Biosystems


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

2430


Enrollment Type:

Actual


Study Dates

Start Date:December 2015
Completion Date:June 2016
Completion Type:Actual
Primary Completion Date:April 2016
Primary Completion Type:Actual
Verification Date:August 2018
Last Changed Date:August 15, 2018
First Received Date:August 25, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Sensitivity
Time Frame:Up to 19 hours post blood collection
Safety Issues:False
Description:The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. PPA will estimated based on the positive T2Bact
Outcome Type:Primary Outcome
Measure:Specificity
Time Frame:Up to 19 hours post blood collection
Safety Issues:False
Description:The primary endpoint of estimated specificity will be determined by comparing the negative blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. NPA will be estimated based on the negative

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Prospective Arm
Study Arm Type:Other
Arm Name:Contrived Arm

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:T2 Biosystems

Samples and Retentions

Study Population: Candidates participating in the prospective arm of the study will come from the hospital population who have had a blood culture ordered per routine standard of care. The contrived arm of the study is open to any participants that meet the study enrollment criteria. The study population for both arms is defined as all subjects who meet the study eligibility criteria, provide informed consent, and provide the clinical specimens under this protocol.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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