Lyme Disease Diagnostic Assay - Collection of Whole Blood
Status unconfirmed
Conditions studied: Lyme Disease, Healthy
In brief
The primary objective is to obtain whole blood from subjects with signs and/or symptoms of early Borrelisois. Whole blood will also be obtained from subjects with suspicion of acute Borreliosis and under medical examination for Lyme disease. In addition, whole blood will be obtained from apparently healthy subjects residing in areas endemic to Lyme disease and may also inlclude apparently healthy subjects residing in areas non-endemic to Lyme disease.
Key facts
- Study ID
- NCT05041595
- Run by
- DiaSorin Inc.
- People needed
- 450
- Starts
- 2021-05-03
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2024-02-20
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- DiaSorin Inc. — Stillwater, Minnesota, United States
Full record on ClinicalTrials.gov
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