Sponsor study identifier
Secondary identifiers
observational
3
1 country
1
Study Start
July 20, 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 11, 2012
Date type not reportedThis date has not been verified as actual or estimated.
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. ...
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 11, 2012
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2006
Date type not reportedThis date has not been verified as actual or estimated.
July 29, 2006
Actual (reported)August 1, 2006
Actual (reported)December 11, 2012
Date type not reportedThis date has not been verified as actual or estimated.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Varela AS, Luttrell MP, Howerth EW, Moore VA, Davidson WR, Stallknecht DE, Little SE. First culture isolation of Borrelia lonestari, putative agent of southern tick-associated rash illness. J Clin Microbiol. 2004 Mar;42(3):1163-9. doi: 10.1128/JCM.42.3.1163-1169.2004.
James AM, Liveris D, Wormser GP, Schwartz I, Montecalvo MA, Johnson BJ. Borrelia lonestari infection after a bite by an Amblyomma americanum tick. J Infect Dis. 2001 Jun 15;183(12):1810-4. doi: 10.1086/320721. Epub 2001 May 17.
Adriana R Marques, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
3 participants (actual enrollment reported by the registry).
First Submitted
July 29, 2006
First Posted
August 1, 2006
Study Start
July 20, 2006
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
Contact the study team to confirm eligibility.
Campbell GL, Paul WS, Schriefer ME, Craven RB, Robbins KE, Dennis DT. Epidemiologic and diagnostic studies of patients with suspected early Lyme disease, Missouri, 1990-1993. J Infect Dis. 1995 Aug;172(2):470-80. doi: 10.1093/infdis/172.2.470.
December 11, 2012
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
December 17, 2019
Record last verified: 2012-12-11
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