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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 : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
T2 Biosystems

Tracking Information
First Submitted Date  ICMJE June 26, 2018
First Posted Date  ICMJE July 10, 2018
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE May 8, 2018
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Lyme Disease
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roger Smith 1-781-457-1200 rsmith@t2biosystems.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03581279
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Plan Description: No data will be shared
Responsible Party T2 Biosystems
Study Sponsor  ICMJE T2 Biosystems
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account T2 Biosystems
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP