Clinical trial: Novel Diagnostics for Early Lyme Disease (NCT03963635)

Eligibility criteria:
Inclusion Criteria:

          1. Human adults at least 21 years of age and no more than 80 years of age at the time of
             screening.

          2. Have the ability to understand the requirements of the study, provide written informed
             consent (including consent for the use and disclosure of research-related health
             information), and comply with the study protocol procedures (including required study
             visits).

          3. High clinical suspicion of acute Lyme disease, with symptoms seven days or less.

          4. Must have erythema migrans rash and physician diagnosis of early Lyme disease.

          5. Brief history and physical exam will be obtained during the study visit.

          6. Be willing to return to our clinic for up to nine visits and blood draws over a
             one-year period.

          7. People who do not have Lyme disease, but want to participate as healthy controls (one
             time visit)

        Exclusion Criteria:

          1. Have poor venous access.

          2. Have received any immunosuppressive therapy including biologics or recent course of
             steroids, or recent chemotherapy.

               1. Anti-TNF therapy (eg, adalimumab, etanercept, infliximab).

               2. Intravenous (IV) cyclophosphamide

               3. Interleukin-1 receptor antagonist (anakinra).

               4. Intravenous immunoglobulin (IVIG).

               5. High dose prednisone or equivalent (> 100 mg/day).

               6. Plasmapheresis.

               7. Any new immunosuppressive/immunomodulatory agent

               8. Any steroid injection (eg, intramuscular, intraarticular, or intravenous).

          3. On treatment for Lyme disease greater than seven days

          4. Recent chemotherapy

          5. History of solid organ transplant

          6. History of autoimmune disorders (SLE, Rheumatoid arthritis, Scleroderma, etc.)

          7. History of inflammatory muscle disease (polymyositis, dermatomyositis, etc.)

          8. History of inflammatory bowel disease (Crohn's disease, Ulcerative colitis, etc.)

          9. History of HIV infection

         10. Received a Lyme disease vaccine in the past

         11. History of prior Lyme disease infection in the past

         12. Have any condition that, in the opinion of the principal investigator, would
             significantly increase the risk for the subject.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 31-year-old woman comes to the office due to 3 days of rash on her left arm.  The lesion is mildly pruritic but not painful.  She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period.  Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease.

Patient description (patient's own words): I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease.

Does the patient match the trial criteria? 1