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

Stopped early · Not applicable

Conditions studied: Lyme Disease

In brief

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.

Key facts

Study ID

NCT03581279

Run by

T2 Biosystems

People needed

18

Starts

2018-05-08

Expected to finish

2019-10-31

Last updated by the study team

2022-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• South County Internal Medicine — Wakefield, Rhode Island, United States
• Gundersen Health System — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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