Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
Primary Purpose
Lyme Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
T2Lyme Panel testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Lyme Disease
Eligibility Criteria
Inclusion Criteria:
- Presence of erythematous skin lesion, consistent with erythema migrans (EM).
- Age 18 or older.
- Ability to read, comprehend, and sign the informed consent form.
- Two (2) or more signs/symptoms of Lyme Disease
Exclusion Criteria:
- Subject has medically diagnosed bleeding disorder.
- Having had taken antibiotics in the past 30 days.
- EM located on face or neck.
- Unable to provide consent.
Sites / Locations
- South County Internal Medicine
- Gundersen Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
EM present
No EM present
Arm Description
All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.
All patients must display signs/symptoms of Lyme disease but do not have an EM lesion.
Outcomes
Primary Outcome Measures
Number of Participants With Lyme Disease Detected in Human Whole Blood Samples
Qualitative detection of genetic material (DNA) from the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as inclusive Borrelia spp.) from K2EDTA human whole blood samples using the T2Dx instrument and T2Lyme reagents.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03581279
Brief Title
Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
Official Title
Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Enrollment levels insufficient to continue.
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
T2 Biosystems
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.
Detailed Description
The objective of this study is to demonstrate the clinical performance of the T2Lyme Panel on the T2Dx instrument. The assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease. The data from this study will be used to support a de novo application for the T2Lyme Panel to the U.S. Food and Drug Administration (FDA) for product approval.
The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
All patients are assigned a unique study ID number to de-identify them.
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EM present
Arm Type
Active Comparator
Arm Description
All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.
Arm Title
No EM present
Arm Type
Active Comparator
Arm Description
All patients must display signs/symptoms of Lyme disease but do not have an EM lesion.
Intervention Type
Device
Intervention Name(s)
T2Lyme Panel testing
Intervention Description
The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples.
Primary Outcome Measure Information:
Title
Number of Participants With Lyme Disease Detected in Human Whole Blood Samples
Description
Qualitative detection of genetic material (DNA) from the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as inclusive Borrelia spp.) from K2EDTA human whole blood samples using the T2Dx instrument and T2Lyme reagents.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of erythematous skin lesion, consistent with erythema migrans (EM).
Age 18 or older.
Ability to read, comprehend, and sign the informed consent form.
Two (2) or more signs/symptoms of Lyme Disease
Exclusion Criteria:
Subject has medically diagnosed bleeding disorder.
Having had taken antibiotics in the past 30 days.
EM located on face or neck.
Unable to provide consent.
Facility Information:
Facility Name
South County Internal Medicine
City
Wakefield
State/Province
Rhode Island
ZIP/Postal Code
02879
Country
United States
Facility Name
Gundersen Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared
Learn more about this trial
Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
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