Clinical trial: Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis (NCT03873974)

Eligibility criteria:
I. Positive trial arm

        I.1. Inclusion Criteria:

          -  Man or female subjects over 18 years of age

          -  Treatment-naive or treatment-experienced subjects with Lyme borreliosis, whose
             physician indicates drug therapy for Lyme borreliosis.

          -  Subjects capable of reading, understanding, and observing the requirements of the
             clinical trial, who sign the Patient Information Leaflet and Informed Consent Form
             approved by the Competent Authority and the Ethics Committee.

        I. 2. Exclusion Criteria:

          -  Man or female subjects over 80 years of age

          -  Pregnancy, breastfeeding

          -  History of any complication related to previous blood sampling

          -  Coagulation and/or bleeding disorders

          -  Anticoagulant therapy

          -  Acute, life-threatening condition

          -  Participation in another clinical trial

          -  The patient is under antibiotic therapy, or received such treatment in the preceding 3
             months

          -  The patient is currently taking or has taken in the preceding 6 months dietary
             supplements of herbal origin, or medicinal herbs as first-line or add-on treatments
             for Lyme borreliosis

          -  In the event the patient has previously been treated for Lyme borreliosis, then this
             treatment took place less than 6 months before blood sampling.

          -  In the preceding 6 months, the patient used an electronic device operating along the
             principle of electromagnetic (i.e. electric or magnetic) fields - such as
             bioresonance, pulsed magnetic field, etc. - as add-on treatment for Lyme borreliosis.

        II. Negative trial arm

        II.1. Inclusion Criteria:

          -  Man or female subjects over 18 years of age

          -  Asymptomatic healthy volunteer subjects without acute or chronic symptoms of Lyme
             borreliosis, who are free of Lyme borreliosis by the indication of all standard
             laboratory tests, and who are willing to take part in a comprehensive medical
             examination and related blood sampling.

          -  Subjects capable of reading, understanding, and observing the requirements of the
             trial, who sign the Patient Information Leaflet and Informed Consent Form approved by
             the Competent Authority and the Ethics Committee.

        II. 2. Exclusion Criteria:

          -  Man or female subjects over 80 years of age

          -  Pregnancy, breastfeeding

          -  History of any complication related to previous blood sampling

          -  Coagulation and/or bleeding disorders

          -  Anticoagulant therapy

          -  Participation in another clinical trial

          -  Lyme borreliosis diagnosed previously, at any time during the life of the subject

          -  The subject has received any treatment for Lyme borreliosis (medicinal products,
             dietary supplements, medicinal plants, electronic devices, etc.) during his/her life

          -  The patient is under antibiotic therapy, or received such treatment in the preceding 3
             months

          -  The occupation of the subject is either a forester or a hunter
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
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? 1