Clinical trial: Investigation of Southern Tick-Associated Rash Illness (STARI) (NCT00358761)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.


Patient description (medical language): A 7-year-old girl is brought to the emergency department by her parents for generalized rash.  The mother reports that she was playing outside wearing a skirt and felt a sharp pain in her arm while seating on a mat, plying with her doll.  Her mother suspects that something had stung her.   The patient's blood pressure is 75/55 mm Hg and her heart rate is 122/min.  Physical examination shows erythematous, raised plaques over the trunk, extremities, and face.  Lung auscultation reveals bilateral expiratory wheezes.

Patient description (patient's own words): I just brought my seven-year-old girl to the ER because she just developed a terrible rash. My little girl was playing outside and she was wearing a lovely little skirt and all of a sudden. She felt like a really sharp pain in her arm. She was sitting on a mat playing with her doll. I think that something stung her. They took her blood pressure, and it turned out to be 75 out of 55. Her heart rate was 122. Then they did a physical examination, and it showed rashes all around her trunk, extremities, and face. Her breath test revealed some high-pitched breathing.

Does the patient match the trial criteria? Contradiction