Study Stopped
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Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
1 other identifier
interventional
18
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2018
CompletedFirst Submitted
Initial submission to the registry
June 26, 2018
CompletedFirst Posted
Study publicly available on registry
July 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedResults Posted
Study results publicly available
January 31, 2022
CompletedFebruary 4, 2022
January 1, 2022
1.5 years
June 26, 2018
October 6, 2021
January 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 day
Study Arms (2)
EM present
ACTIVE COMPARATORAll patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.
No EM present
ACTIVE COMPARATORAll patients must display signs/symptoms of Lyme disease but do not have an EM lesion.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- T2 Biosystemslead
Study Sites (2)
South County Internal Medicine
Wakefield, Rhode Island, 02879, United States
Gundersen Health System
La Crosse, Wisconsin, 54601, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager, Regulatory and Clinical Affairs
- Organization
- MDC Associates, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- All patients are assigned a unique study ID number to de-identify them.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2018
First Posted
July 10, 2018
Study Start
May 8, 2018
Primary Completion
October 31, 2019
Study Completion
October 31, 2019
Last Updated
February 4, 2022
Results First Posted
January 31, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
No data will be shared