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Investigation of Southern Tick-Associated Rash Illness (STARI)


N/A
14 Years
N/A
Not Enrolling
Both
Southern Tick-Associated Rash Illness

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Trial Information

Investigation of Southern Tick-Associated Rash Illness (STARI)


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.

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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Frank Maldarelli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

060207

NCT ID:

NCT00358761

Start Date:

July 2006

Completion Date:

December 2012

Related Keywords:

  • Southern Tick-Associated Rash Illness
  • Lone Star Tick
  • Borrelia
  • Skin Biopsy
  • Spirochete
  • Erythema Migrans
  • Southern Tick-Assoicated Rash Illness
  • STARI
  • Exanthema

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892
National Center for Infectious DiseaseFort Collins, Colorado