Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358761
Status:
TERMINATED
Last Update Posted:
2019-12-17
First Post:
2006-07-29
Brief Title:
Investigation of Southern Tick-Associated Rash Illness STARI
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Investigation of Southern Tick-Associated Rash Illness STARI
Status:
TERMINATED
Status Verified Date:
2012-12-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 1-12 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 patients 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
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 1-12 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 patients 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
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 the lone star tick Amblyomma americanum The cause of the rash is unknown as it is the natural course of the disease This protocol aims to investigate the cause of STARI in conjunction with the Center for Disease Control and Prevention CDC Skin biopsies and blood samples will be taken from patients with suspected STARI and will be used to search for an infectious agent and to develop diagnostic tests for the disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-0207 | None | None | None |