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Lyme Xenodiagnosis Phase II Study
||Xenodiagnosis after Antibiotic for Lyme Disease - Phase 2 Study
||Linden Hu, MD
Recent studies have shown that the causative agent of Lyme disease, the organism (Borrelia burgdorferi), may persist in animals after antibiotic treatment and can be detected by using natural tick vector (Ixodes scapularis) to acquire the organism through feeding (xenodiagnosis). The aim of this study is to investigate the utility of xenodiagnosis for identifying persistence of infection with B. burgdorferi in treated human Lyme disease.
Our objectives include: (1) assessing the link between the detection of B. burgdorferi by xenodiagnosis and the persistence of symptoms in patients diagnosed with Lyme disease, (2) comparing the rate of detection of B. burgdorferi by xenodiagnosis after therapy in participants with posttreatment Lyme disease symptoms, (3) identifying subject characteristics related to the likelihood of detecting B. burgdorferi by xenodiagnosis, and (4) continuing to evaluate the safety of xenodiagnosis in humans.
- Been diagnosed with confirmed or probable Lyme disease fulfilling the case definition of Lyme disease by the CDC.
- Received antibiotic therapy for Lyme disease.
- History of allergy or severe reaction to surgical tape, surgical dressings, or tick bites.
- Women who are pregnant or lactating.
- One of the following existing conditions, active severe skin disease, uncontrolled diabetes, cancer other than non-melanoma skin cancers, autoimmune disease requiring immunosuppressive therapy, or history of HIV, chronic viral hepatitis, or syphilis
Participation in this study will last from 3-12 months and can include between 4-6 study visits, as well as additional tick placement visits if necessary, Each study visit will last between 1-3 hours and will include the administration of questionnaires, a brief health assessment, and blood draw. The volume of blood collected will depend on the visit type and varies from 9mL to 50mL. The study will include the placement of roughly 50 larval Ixodes scapularis
ticks, which will then be removed 4-6 days later. These ticks are laboratory raised and tested for all known human diseases carried by the Ixodes scapularis
tick. Eligible subjects may also elect to participate in optional skin biopsies.