Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
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ClinicalTrials.gov Identifier: NCT03581279 |
Recruitment Status :
Completed
First Posted : July 10, 2018
Last Update Posted : January 29, 2020
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Tracking Information | |||||||||
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First Submitted Date ICMJE | June 26, 2018 | ||||||||
First Posted Date ICMJE | July 10, 2018 | ||||||||
Last Update Posted Date | January 29, 2020 | ||||||||
Actual Study Start Date ICMJE | May 8, 2018 | ||||||||
Actual Primary Completion Date | October 31, 2019 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Detection of Lyme Disease in human whole blood samples [ Time Frame: 1 day ] | ||||||||
Change History | |||||||||
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. |
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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
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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.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Actual Enrollment ICMJE |
18 | ||||||||
Original Estimated Enrollment ICMJE |
300 | ||||||||
Actual Study Completion Date ICMJE | October 31, 2019 | ||||||||
Actual Primary Completion Date | October 31, 2019 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | T2 Biosystems | ||||||||
Study Sponsor ICMJE | T2 Biosystems | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | T2 Biosystems | ||||||||
Verification Date | January 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |