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

Lyme Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03581279
• Other study ID #: PRO-000879
• Status: Terminated
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: January 2022
• Source: T2 Biosystems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lyme Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Gundersen Health System	La Crosse	Wisconsin
United States	South County Internal Medicine	Wakefield	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
T2 Biosystems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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