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

What this Trial Is About

Lyme disease is a multisystem illness caused by the bacteria Borrelia burgdorferi and is the most common vector-borne illness in the United States. This research aims to create a well-defined group of patients with active Lyme disease to study various aspects of the infection, including biological markers, clinical outcomes, and immune responses. The study involves evaluation, treatment, and follow-up of these patients to better understand the disease and improve care. Participants in this observational study will receive standard medical care with FDA-approved medications given according to accepted doses and methods. Their condition will be assessed through medical history, physical exams, and appropriate diagnostic tests such as blood and urine tests, X-rays, imaging studies, cultures, skin biopsies, and allergy or immune response tests. Some adult participants may also undergo leukapheresis, a procedure to collect white blood cells, for research purposes. Patients will be followed over time, with visits generally scheduled at the end of therapy, then 3, 6, and 12 months later, and subsequently every 6 to 12 months as needed. Researchers will monitor the disease course and immune response through additional blood draws and clinical evaluations. The main goal is to develop a patient population database to support ongoing research on Lyme disease. The study duration extends through 2030 with careful safety and health monitoring throughout.

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