Evaluation, Treatment, and Follow-up of Patients With Lyme Disease

What this Trial Is About

Researchers are studying Lyme disease, a multisystem illness caused by the Borrelia burgdorferi bacteria, which is the most common vector-borne illness in the United States. This observational study aims to develop a well-defined group of patients with active Lyme disease to better understand the infection, its biological markers, clinical course, outcomes, and the immune response to this infection. Participants with active Lyme disease will receive evaluation, standard treatment, and follow-up care. Treatments include only FDA-approved medications given according to accepted doses and methods. The study does not involve experimental procedures. Diagnostic evaluations may include medical history, physical exams, blood and urine tests, imaging studies, cultures, skin biopsies, and allergy or immune response tests. Some adults may undergo leukapheresis to collect white blood cells for research. Participants will be monitored through regular visits, generally at the end of therapy, then at 3, 6, and 12 months, followed by visits every 6 to 12 months as needed. Research procedures may include extra blood draws for studying Lyme disease and inflammatory conditions, with limits on blood volume drawn. Researchers will track clinical outcomes and immune responses over time to inform future Lyme disease research and treatment strategies.

Evaluation, Treatment, and Follow-up of Patients With Lyme Disease