Clinical trial: A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease (NCT02741609)

Eligibility criteria:
Inclusion Criteria:

          1. Subject must provide written informed consent prior to the conduct of any
             study-related procedures.

          2. Male or female subjects who are at least 18 years of age.

          3. Subjects are suspected to have early Lyme disease based on the following criteria:
             Signs, symptoms and clinical history consistent with early-stage Lyme disease.
             Subjects must have a medical practitioner-diagnosed erythema migrans (EM) rash and
             should have systemic symptoms indicative of disseminated infection. Symptoms may
             include fever, headache, fatigue, myalgias, arthralgias, and stiff neck. Paired acute
             and convalescent titers will be drawn (first draw at time of initial visit and second
             draw 4 weeks later) or,

          4. Subjects are suspected to have late Lyme disease based on the following criteria:
             Signs, symptoms and clinical history consistent with late stage Lyme disease,
             including but not limited to disseminated rash, arthritis, meningitis, facial palsy,
             or carditis.

          5. Subjects must be willing and have the ability to safely have the required quantity of
             blood drawn for the study at the discretion of the investigator.

          6. Subjects must have blood samples freshly collected (no supplemental frozen samples)
             and the samples must reach ALSI's laboratory on a weekday and within 24 hours of being
             drawn.

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        Exclusion Criteria:

          1. Early Lyme disease: Subjects without an EM rash or do not have symptoms recognized as
             being associated with Lyme disease.

          2. Exposure to antibiotics of any type during the 6 weeks prior to the initial blood
             sample collection.

          3. Immune deficiency significant enough to render serological tests less reliable.

          4. The subject is unwilling or unable to safely have the required quantity of blood drawn
             for this study.

          5. Subjects who are not able to understand all of the requirements of the study or unable
             to give informed consent and/or comply with all aspects of the evaluation.

          6. Subjects that have any other condition or situation which, in the opinion of the
             investigator, would make the subject unsuitable for enrollment or could interfere with
             the subject participating in and completing the study.

          7. Subjects that have undergone testing for Lyme disease within the past year.

          8. Subjects that have a prior diagnosis of Lyme disease.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 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? Entailment