Southern Tick-Associated Rash Illness Clinical Trial
Official title:
Investigation of Southern Tick-Associated Rash Illness (STARI)
| Verified date | December 11, 2012 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study will evaluate blood and tissue samples for a condition called Southern
Tick-Associated Rash Illness (STARI). This is a skin rash resembling erythema migrans, the
rash found in people infected with Lyme disease. In the south and southeastern United States,
STARI is associated with the bite of the lone star tick. Researchers seek a better
understanding of the cause of STARI. Through researchers' knowledge, diagnostic tests could
be developed. NIH is conducting this study along with the Centers for Disease Control and
Prevention (CDC).
Patients ages 14 years and older who have recently been diagnosed with possible STARI, who
have not taken antibiotics for it longer than 1 day, and whose skin does not form large scars
may be eligible for this study. About 20 participants will be enrolled over a 5-year period.
Patients will visit the NIH Clinical Center for two or three visits. The first visit may last
2 hours. Photographs will be taken of the rash, and a blood sample of about 1-1/2 tablespoons
will be collected for tests. Patients will undergo a punch biopsy of three small pieces of
skin, from the rash. The area of the skin will be cleaned, and patients will receive a local
anesthetic at the biopsy site. A sharp instrument will remove a round plug of skin, about the
size of half a pencil eraser. Patients may feel a pushing sensation, but there should not be
pain. The site usually heals without sutures, though the doctors may close it with special
adhesive bandages or one or two sutures. Patients will receive instructions about how to take
care of the biopsy site. If sutures are used, patients will return in 7 to 10 days to have
them removed-or a patient's own doctor may remove the sutures. Patients will return to NIH at
4 to 6 weeks following their first visit. At that time, they will answer questions about how
they are doing and donate about 2 tablespoons of blood. Blood and skin samples will be used
for research at NIH and CDC.
...
| Status | Terminated |
| Enrollment | 3 |
| Est. completion date | December 11, 2012 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 14 Years and older |
| Eligibility |
- 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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