PROTOCOL TITLE: CHARACTERIZATION OF PEDIATRIC LYME DISEASE: CLINICAL MANIFESTATIONS, LONG TERM OUTCOME, IMMUNE RESPONSE AND PREVALANCE OF PTLDS
The protocol proposes two paired substudies designed to characterize the clinical manifestations and long-term outcomes among pediatric Lyme disease patients in the greater Washington, DC area. Substudy 1 will characterize the natural history and longterm clinical, quality of life, and cognitive outcome of pediatric patients diagnosed with early and late stage Lyme disease, including prevalence of Post-Treatment Lyme Syndrome (PTLDS) and Substudy 2 will compare clinical, behavioral, cognitive and(future) immunologic response profiles between patients with full recovery, PTLDS and healthy controls. We will assess timeframe for resolution of symptoms after appropriate treatment, estimate the prevalence of PTLDS among a diverse cohort of pediatric patients diagnosed with Lyme disease within the past decade, and obtain specimens for future studies to identify the immune response of patients with PTLDS compared to patients who fully recovered from Lyme disease and healthy controls, as well as recently diagnosed patients with different manifestations of Lyme disease (early localized, disseminated, and late disease). Results of these analyses will be used to identify profiles and biomarkers that correlate with the outcome phenotypes. This signature could allow the design of a prognostic/diagnostic biomarker assays for patients with Lyme disease and PTLDS.