Lyme Disease Diagnostic Assay - Collection of Whole Blood

• Conditions: Lyme Disease; Healthy
• Interventions: Diagnostic Test: Lyme diagnostic assay

• Registration Number: NCT05041595
• Lead Sponsor: DiaSorin Inc.

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.

Study Timeline

• Study Start: 2021-05-03
• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-13
• Primary Completion: 2023-12-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sick Cohort	Lyme diagnostic assay	Borreliosis Subjects - All comers expressing signs and symtoms consistent with suspicion of acute Borreliosis and under medical examination for Lyme disease Borreliosis subjects with an Erythema Migrans Rash (subgroup)
Apparently Healthy	Lyme diagnostic assay	Apparently healthy subjects living in an area non-endemic for Lyme disease Apparently healthy subjects living in an area endemic for Lyme disease

Primary Outcome Measures

Name	Time	Method
Clinical Performance - Sensitivity	Through study completion, an average of 1 year	Diagnostic Sensitivity

Secondary Outcome Measures

Name	Time	Method
Clinical Performance - Specificity	Through study completion, an average of 1 year	Diagnostic Specificity

Trial Locations

Locations (1)

DiaSorin Inc.; 🇺🇸 Stillwater, Minnesota, United States