Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel

• Sponsor: T2 Biosystems (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03581279
• Collaborator: (none)
• Enrollment: 18
• Locations: 2
• Arms: 2
• Actual Duration (Months): 17.8
• Patients Per Site: 9
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lyme Disease	Device: T2Lyme Panel testing	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: All patients are assigned a unique study ID number to de-identify them.
• Primary Purpose: Diagnostic
• Official Title: Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
• Actual Study Start Date: May 8, 2018
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: EM present All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.	Device: T2Lyme Panel testing; 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.
Active Comparator: No EM present All patients must display signs/symptoms of Lyme disease but do not have an EM lesion.	Device: T2Lyme Panel testing; 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Lyme Disease Detected in Human Whole Blood Samples [1 day]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South County Internal Medicine	Wakefield	Rhode Island	United States	02879
2	Gundersen Health System	La Crosse	Wisconsin	United States	54601

Sponsors and Collaborators

• T2 Biosystems

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 1, 2018

More Information

Publications

None provided.

• Responsible Party: T2 Biosystems
• ClinicalTrials.gov Identifier: NCT03581279
• Other Study ID Numbers: PRO-000879
• First Posted: Jul 10, 2018
• Last Update Posted: Feb 4, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Lyme Disease

Study Results

Participant Flow

Arm/Group Title	EM Present	No EM Present
Arm/Group Description	All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion. T2Lyme Panel testing: 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.	All patients must display signs/symptoms of Lyme disease but do not have an EM lesion. T2Lyme Panel testing: 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.
Period Title: Overall Study
STARTED	18	0
COMPLETED	16	0
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	EM Present	No EM Present	Total
Arm/Group Description	All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion. T2Lyme Panel testing: 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.	All patients must display signs/symptoms of Lyme disease but do not have an EM lesion. T2Lyme Panel testing: 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.	Total of all reporting groups
Overall Participants	18	0	18
Age (Count of Participants)
<=18 years	0 0%	0 NaN	0 0%
Between 18 and 65 years	8 44.4%	0 NaN	8 44.4%
>=65 years	10 55.6%	0 NaN	10 55.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (12)	66 (12)
Sex: Female, Male (Count of Participants)
Female	4 22.2%	0 NaN	4 22.2%
Male	14 77.8%	0 NaN	14 77.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN
Asian	0 0%	0 NaN
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN
Black or African American	0 0%	0 NaN
White	0 0%	0 NaN
More than one race	0 0%	0 NaN
Unknown or Not Reported	18 100%	18 Infinity
Region of Enrollment (participants) [Number]
United States	18 100%	11 Infinity

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The "No EM present" arm of the study was never initiated.

Arm/Group Title	EM Present	No EM Present
Arm/Group Description	All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion. T2Lyme Panel testing: 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.	All patients must display signs/symptoms of Lyme disease but do not have an EM lesion. T2Lyme Panel testing: 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.
Measure Participants	18	0
Count of Participants [Participants]	18 100%	0 NaN

Adverse Events

Time Frame	45 - 60 days
Adverse Event Reporting Description	No participants were enrolled in the "no EM present" arm of the study.
Arm/Group Title	EM Present		No EM Present
Arm/Group Description	All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion. T2Lyme Panel testing: 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.		All patients must display signs/symptoms of Lyme disease but do not have an EM lesion. T2Lyme Panel testing: 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.
All Cause Mortality
	EM Present		No EM Present
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/0 (NaN)
Serious Adverse Events
	EM Present		No EM Present
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	EM Present		No EM Present
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.