Investigation of Southern Tick-Associated Rash Illness (STARI)

Inclusion Criteria

- INCLUSION CRITERIA:

Enrolled in protocol 02-I-0055.

A person who is at least 14 years old.

Acute onset (within 14 days of visit to NIH) of an annular, erythematous, expanding
erythema migrans (EM)-like rash that attains a size of at least 5 cm in diameter, when no
alternative explanation for the rash can be found, and thought by the study physician to
have a high likelihood to be due to STARI (due to exposure history, tick identification).

History of tick bite at the rash site, or potential exposure to ticks in the southeastern
and south central United States within 14 days prior to rash onset (including Maryland and
Virginia).

Consent to storage of biologic samples for later testing.

EXCLUSION CRITERIA:

A person who, in the judgment of the investigator, would be at increased risk from the
skin biopsy procedure and unlikely to be able to mount a serological response to the agent
(for example, bone marrow transplant, B cell deficiency).

EXCLUSION FROM SKIN BIOPSY PORTION OF STUDY:

A person who meets the case definition but whose EM-like rash occurs on the face, neck,
scalp, or over the tibia will not be enrolled for purposes of obtaining a skin biopsy
specimen. Such a person may enroll for purposes of providing a clinical history and blood
samples only. This exclusion also applies to patients with a history of forming large
thick scars after skin injuries or surgery, or who have a history of excessive bleeding
after cuts or procedures or are taking anticoagulants, or have severe skin disease. Also,
patients who have received more than 24 hours of antibiotic treatment for the rash will be
excluded from the biopsy. Patient with a history of allergy to lidocaine will also be
excluded from the biopsy portion of the study.