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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03581279
Recruitment Status : Terminated (Enrollment levels insufficient to continue.)
First Posted : July 10, 2018
Results First Posted : January 31, 2022
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
T2 Biosystems

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of Participants With Lyme Disease Detected 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581279


Locations
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United States, Rhode Island
South County Internal Medicine
Wakefield, Rhode Island, United States, 02879
United States, Wisconsin
Gundersen Health System
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
T2 Biosystems
  Study Documents (Full-Text)

Documents provided by T2 Biosystems:
Study Protocol  [PDF] October 1, 2018
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Responsible Party: T2 Biosystems
ClinicalTrials.gov Identifier: NCT03581279    
Other Study ID Numbers: PRO-000879
First Posted: July 10, 2018    Key Record Dates
Results First Posted: January 31, 2022
Last Update Posted: February 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared

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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
Additional relevant MeSH terms:
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Lyme Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
 Borrelia Infections
Spirochaetales Infections
Tick-Borne Diseases
Vector Borne Diseases