Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01143558
Study Brief:
Protocol Section:
NCT01143558