Clinical trial: Searching for Persistence of Infection in Lyme Disease (NCT01143558)

Eligibility criteria:
-  INCLUSION CRITERIA:

        Criteria for the diagnosis of Lyme disease can be found at The clinical assessment,
        treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis:
        clinical practice guidelines by the Infectious Diseases Society of America (4).

          1. Patients With EM (N=35), Post Treatment

               -  Age 18 or older

               -  EM diagnosed by the study physician or, with a diagnosis of EM that is thought to
                  be highly likely by the study physician.

               -  Treatment with at least 1 course of antibiotics that fulfills the Infectious
                  Diseases Society of America guidelines for the recommended therapy for Lyme
                  disease. There must be at least 1 month and up to 4 months between the end of the
                  therapy and the study procedures.

          2. High C6 Antibody Titer (N=35)

               -  Age 18 or older

               -  Diagnosed with confirmed or probable early or late Lyme disease as per Centers
                  for Disease Control and Prevention (CDC) case definition
                  (http://www.cdc.gov/ncphi/disss.nndss/caseded/lyme disease 2008.htm), have
                  received recommended antibiotic therapy and have a high C6 ELISA titer (index
                  above 3) at least 6 months after therapy.

          3. Post Lyme disease syndrome (N=20)

               -  Age 18 or older

               -  Diagnosed with confirmed or probable early or late Lyme disease fulfilling the
                  case definition of Lyme disease by the CDC
                  (http://www.cdc.gov/ncphi/disss.nndss/caseded/lyme disease 2008.htm)

               -  Received recommended antibiotic therapy, with resolution or stabilization of the
                  objective manifestation(s) of Lyme disease.

               -  New complaints of fatigue, paresthesias or dysesthesias, widespread
                  musculoskeletal pain or cognitive difficulties within 6 months of the diagnosis
                  of Lyme disease

               -  Symptoms are persistent or relapsing for at least a 6-month period after
                  completion of antibiotic therapy, causing reduction in previous levels of
                  occupational, educational, social, or personal activities.

               -  No antibiotic therapy active against Lyme disease in the previous 3 months.

          4. Patients With EM (N=20), On Treatment

               -  Age 18 or older

               -  EM diagnosed by the study physician and receiving antibiotic therapy for less
                  than 48 hours.

          5. Lyme Arthritis (N=10)

               -  Age 18 or older

               -  Lyme arthritis and have not received therapy.

          6. Healthy Volunteers (N=30)

               -  Age 18 or older

               -  No history of Lyme disease

               -  Negative whole-cell Borrelia ELISA or C6 ELISA

               -  Living in an endemic area for Lyme disease.

        EXCLUSION CRITERIA:

          -  History of allergy to surgical tape or Nitex nylon mesh

          -  History of severe reactions to tick bites (granuloma or systemic reactions)

          -  Inability to maintain the dressing for any reason

          -  Currently receiving any antibiotic or having received antibiotics in the last month (3
             months for patients with post Lyme disease syndrome and high C6 titer) (except
             patients with EM on treatment)

          -  Pregnancy or lactation

          -  Unwillingness to use an effective method of birth control for 3 months after tick
             placement (women of child-bearing potential only)

          -  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.

          -  Investigational therapy during the time of the study and/or in the month prior to
             signing the informed consent.

          -  Active severe skin disease, uncontrolled diabetes, cancer other than non-melanoma skin
             cancers, autoimmune disease requiring immunosuppressive therapy, or history of HIV,
             chronic viral hepatitis, or syphilis.

          -  Oral steroids in the previous 2 weeks (nasal steroids and replacement doses of
             steroids are not exclusions)

          -  Any other condition that, in the opinion of the investigator, would make the patient
             unsuitable for enrollment or could interfere with the patient participating in and
             completing the study.

        EXCLUSION FROM SKIN BIOPSY PART OF THE PROTOCOL:

          -  History of forming large thick scars after skin injuries or surgery

          -  History of excessive bleeding after cuts or procedures

          -  Currently taking anticoagulants

          -  History of allergy to lidocaine

          -  Biopsies will not be done on face, neck, scalp, or over the tibia
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