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

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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

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.




Primary Outcome Measures :
  1. Detection of Lyme Disease in human whole blood samples [ Time Frame: 1 day ]


Information from the National Library of Medicine

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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.

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


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

Locations
United States, Rhode Island
South County Internal Medicine Recruiting
Wakefield, Rhode Island, United States, 02879
Contact: Dawn Buckley, MD    401-789-0283    dbuckley@scim.necoxmail.com   
Principal Investigator: Nitin S Damle, MD         
United States, Wisconsin
Gundersen Health System Not yet recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Dean Jobe       dajobe@gundersenhealth.org   
Principal Investigator: Steve Callister, MD         
Sponsors and Collaborators
T2 Biosystems

Responsible Party: T2 Biosystems
ClinicalTrials.gov Identifier: NCT03581279     History of Changes
Other Study ID Numbers: PRO-000879
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared

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:
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections