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

• ClinicalTrials.gov Identifier: NCT03581279
• Recruitment Status: Recruiting
• First Posted: July 10, 2018
• Last Update Posted: May 6, 2019
• Sponsor: T2 Biosystems
• Information provided by (Responsible Party): T2 Biosystems

Tracking Information

• First Submitted Date: June 26, 2018
• First Posted Date: July 10, 2018
• Last Update Posted Date: May 6, 2019
• Actual Study Start Date: May 8, 2018
• Estimated Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2018)

Detection of Lyme Disease in human whole blood samples [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: June 26, 2018): Detection of Lyme Disease in human whole blood samples [ Time Frame: 1 day ]
• Change History: Complete list of historical versions of study NCT03581279 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
• Official Title: Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: 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.

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 26, 2018): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2019
• Estimated Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Roger Smith; 1-781-457-1200; rsmith@t2biosystems.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03581279
• Other Study ID Numbers: PRO-000879
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: No data will be shared

• Responsible Party: T2 Biosystems
• Study Sponsor: T2 Biosystems
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: T2 Biosystems
• Verification Date: May 2019