Status:
TERMINATED
Investigation of Southern Tick-Associated Rash Illness (STARI)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Southern Tick-Associated Rash Illness
Eligibility:
All Genders
14+ years
Brief Summary
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 infect...
Detailed Description
Southern Tick-Associated Rash Illness (STARI) is a rash similar to the rash of Lyme disease that occurs in persons residing in southeastern and south-central states and is associated with the bite of ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 20 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 11 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00358761
Start Date
July 20 2006
End Date
December 11 2012
Last Update
December 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892