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Enrollment levels insufficient to continue.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EM present | Active Comparator | All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion. |
|
| No EM present | Active Comparator | All patients must display signs/symptoms of Lyme disease but do not have an EM lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2Lyme Panel testing | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Lyme Disease Detected in Human Whole Blood Samples | 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South County Internal Medicine | Wakefield | Rhode Island | 02879 | United States | ||
| Gundersen Health System |
No data will be shared
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| ID | Title | Description |
|---|---|---|
| FG000 | EM Present | All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion. 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. |
| FG001 | No EM Present | All patients must display signs/symptoms of Lyme disease but do not have an EM lesion. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The "No EM present" arm of this study was never initiated.
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| ID | Title | Description |
|---|---|---|
| BG000 | EM Present | All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Lyme Disease Detected in Human Whole Blood Samples | 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. | The "No EM present" arm of the study was never initiated. | Posted | Count of Participants | Participants | 1 day |
|
45 - 60 days
No participants were enrolled in the "no EM present" arm of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EM Present | All patients must display signs/symptoms of Lyme disease as well as exhibit an EM lesion. 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Regulatory and Clinical Affairs | MDC Associates, Inc. | 9787055012 | t2@mdcassoc.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2018 | Dec 29, 2021 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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All patients are assigned a unique study ID number to de-identify them.
|
| La Crosse |
| Wisconsin |
| 54601 |
| United States |
| BG001 | No EM Present | All patients must display signs/symptoms of Lyme disease but do not have an EM lesion. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No EM Present | All patients must display signs/symptoms of Lyme disease but do not have an EM lesion. 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. |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | No EM Present | All patients must display signs/symptoms of Lyme disease but do not have an EM lesion. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |