Clinical trial: Lyme Test Indication Combinations (LyTIC) Study (NCT03201042)

Eligibility criteria:
Inclusion Criteria:

          -  Cohort 1a (typical EM and intention to treat):

        Inclusion

          1. Documented new onset Lyme disease EM rash (single or multiple) with photographic
             evidence provided to Oxford Immunotec.

          2. Patient must be able to provide blood sample at the initial visit (prior to treatment
             initiation) and subsequent samples according to the schedule.

          3. Patients 5 years of age or older, with a minimum weight of 40 pounds.

          4. Patient able to read English and to give consent to study participation.

          5. If patient is younger than 18 years of age a legally authorized representative must
             provide consent.

        Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):

        Inclusion

          1. Patients with suspected Lyme disease, based on physician's examination, where the
             physician has the intention to treat for Lyme disease (i.e. patients who following
             initial examination were prescribed treatment for Lyme disease).

          2. Documented new onset of Lyme disease symptoms without a typical EM rash or with no
             rash. If a rash is present, photographic evidence must be provided.

          3. Patient must be able to provide blood sample at the initial visit (prior to treatment
             initiation) and subsequent samples according to the schedule.

          4. Patients 5 years of age or older, with a minimum weight of 40 pounds.

          5. Patient able to read English and to give consent to study participation.

          6. If patient is younger than 18 years of age a legally authorized representative must
             provide consent.

        Cohort 2 (Healthy subjects):

        Inclusion

          1. Subjects 5 years of age or older, with a minimum weight of 40 pounds.

          2. Subjects never diagnosed with any tick borne disease including Lyme disease

          3. Subjects able to read English and to give consent to study participation.

          4. If subject is younger than 18 years of age a legally authorized representative must
             provide consent.

        Exclusion Criteria:

          -  Exclusion Cohort 1a (typical EM and intention to treat):

               1. Patients with Lyme-like symptoms lasting longer than 1 month prior to study
                  enrolment.

               2. Patients receiving treatment for any tick borne disease (including Lyme disease)
                  prior to enrolment.

               3. Patients who received a Lyme vaccination.

               4. Patients with anemia defined as a serum hemoglobin <10gm/dL.

               5. Patients who are participating in, or plan to participate in, any investigational
                  drug study.

               6. Patients who are considered unsuitable for the study by the Investigator.

        Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):

          1. Patients with Lyme-like symptoms lasting longer than 1 month prior to study enrolment.

          2. Patients receiving treatment for any tick borne disease (including Lyme disease) prior
             to enrolment.

          3. Patients who received a Lyme vaccination.

          4. Patients with anemia defined as a serum hemoglobin <10gm/dL.

          5. Patients who are participating in, or plan to participate in, any investigational drug
             study.

          6. Patients who are considered unsuitable for the study by the Investigator.

        Cohort 2 (Healthy subjects):

        Exclusion

          1. Subjects with a history of tick bite

          2. Subjects with past or current tick borne disease diagnosis

          3. Subjects at risk for tick borne diseases including Lyme disease

          4. Subjects residing in endemic regions for tick borne diseases: Connecticut, Delaware,
             Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York,
             Pennsylvania, Rhode Island, Vermont, Virginia and Wisconsin.

          5. Subjects who have ever visited non-urban areas of endemic regions for tick borne
             diseases: Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New
             Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia and
             Wisconsin.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.


Patient description (medical language): A 31-year-old woman comes to the office due to 3 days of rash on her left arm.  The lesion is mildly pruritic but not painful.  She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period.  Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease.

Patient description (patient's own words): I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease.

Does the patient match the trial criteria? Contradiction