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:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-24 @ 1:27 PM
NCT ID:
NCT05041595
Eligibility Criteria:
Subjects with under evaluation of Lyme Disease
Inclusion Criteria:
Signs and symptoms of acute Lyme disease which include at least one of the following:
* Recent onset of fatigue
* Skin rash
* Fever
* Muscle aches
* Neck pain
* Joint pain or lymphadenopathy
Subgroup Borreliosis Subjects- restricted signs and symptoms of acute Lyme including EM Rash
* Under physician or medical evaluation for acute on-set of Lyme Disease presenting with EM Rash
* Detailed description of the EM rash (e.g. Itchy, painful, hot, vesicular, raised) with consent for photographic documentation is required including additional picture with ruler placing to confirming size.
* EM rash with the following attributes:
* Size \> 5 cm in diameter
* Appeared 3-30 days after bite or suspected bite
* Specify Location (e.g. underarm or back of knee)
* Subjects with confirmed early localized or disseminated Lyme Borreliosis manifestation
* Signs and symptoms (e.g. Fever, Chills/Sweats, Headache, Fatigue/Tiredness, Myalgia/Sore muscles)
* The EM rash has been present \<42 days
* Clinical diagnosis of Lyme disease is suspected by the practitioner
* Ability to provide the minimum sample volume required
Exclusion Criteria:
* Subjects unable to provide informed consent.
* Subjects without clinical information and/or not meeting inclusion criteria.
* Subjects having started antibiotic treatment \> 5 days before inclusion.
Healthy Subjects
Inclusion Criteria:
* Apparently healthy subjects with no present fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes, e.g. flu-like symptoms.
* Ability to provide the minimum sample volume required.
Exclusion Criteria:
\- ● Subjects unable to provide informed consent
* Subjects without clinical information and/or not meeting inclusion criteria
* Subjects with a recent diagnosis of Lyme disease, Anaplasmosis, Babesiosis, or history of known embedded tick bite which may have required 'manual extraction' NOTE: a tick just found on the subject or presence of a crawling tick is not considered a 'tick bite')
* Subjects currently on antibiotic treatment.
* Uncontrolled HIV-infection, if known. This is defined as an HIV-1 viral load \>40 copies/mL and/or CD4+ count \<500 x 106 cells/liter in the past 12 months.
* Active syphilis or leptospirosis, if known
* Active infection with Epstein Barr Virus (mononucleosis), if known
* Active infection with Cytomegalovirus (CMV), if known
* Subjects with autoimmune diseases, either confirmed rheumatoid arthritis and/or other autoimmune disorders diagnosed according to the leading guidelines
* Current immunomodulation mediation including \>7.5 mg prednisone daily, methotrexate, and/or biologicals. Medications such as hydroxychloroquine, sulfasalazine or NSAIDs are acceptable.
* Immunodeficiency, hematologic malignancies in the medical history
* Chemotherapy during the past year
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05041595
Study Brief:
Protocol Section:
NCT05041595