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

Not Applicable

Terminated

• Conditions: Lyme Disease
• Interventions: Device: T2Lyme Panel testing

• Registration Number: NCT03581279
• Lead Sponsor: T2 Biosystems

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.

Study Timeline

• Study Start: 2018-05-08
• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-10
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Results First Submitted: 2021-10-06
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-27
• Last Update Submitted: 2022-01-28
• Results First Posted: 2022-01-31
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No EM present	T2Lyme Panel testing	All patients must display signs/symptoms of Lyme disease but do not have an EM lesion.
EM present	T2Lyme Panel testing	All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Gundersen Health System; 🇺🇸 La Crosse, Wisconsin, United States

South County Internal Medicine; 🇺🇸 Wakefield, Rhode Island, United States