Trial Outcomes & Findings for Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel (NCT NCT03581279)

Last Updated: 2022-02-04

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

1 day

Results posted on

2022-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	EM Present 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.	No EM Present 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.
Overall Study STARTED	18	0
Overall Study COMPLETED	16	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EM Present n=18 Participants 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.	No EM Present 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 n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 12 • n=5 Participants	—	66 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	0 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants	—	18 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	—	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

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

Outcome measures

Outcome measures
Measure	EM Present n=18 Participants 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.	No EM Present 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.
Number of Participants With Lyme Disease Detected in Human Whole Blood Samples	18 Participants	0 Participants

Adverse Events

EM Present

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No EM Present

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Regulatory and Clinical Affairs

MDC Associates, Inc.

Phone: 9787055012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place