Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT03963635
Study Brief:
Protocol Section:
NCT03963635