Clinical trial NCT05041595: Lyme Disease Diagnostic Assay - Collection of Whole Blood
Official title: Collection of Whole Blood to be Used to Provide the Safety and Effectivenss of a Lyme Disease Diagnostic Assay to Support the Proposed Intended Use Statement and Product Labeling Claims.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lyme Disease
Healthy
Lead sponsor: DiaSorin Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-13
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with suspected Borreliosis including subjects with EM rash and subjects without EM rash but with signs and symptoms consistent with suspicion of acute Borreliosis and under medical examination for Lyme disease.

Healthy subjects living in endemic Lyme disease area and healthy subjects living in a non-endemic Lyme disease area.

Brief summary: 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.

Detailed description: Whole blood will be collected, and processed. Some blood will be transferred to additional tubes for further processing and aliquotting. Serum and plasma will be harvested and tested, at a later date, in a clinical performance study with approved and/or commercially available devices as well as an investigational Lyme assay. This study will be coordinated by the Sponsor.

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

Primary outcomes:
measure: Clinical Performance - Sensitivity
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Clinical Performance - Specificity
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: DiaSorin Inc.
state: Minnesota
Study officials:
References: