Lyme Disease Diagnostic Assay - Collection of Whole Blood

NCT05041595 | Enrolling By Invitation FDA Device

• 1 other identifier: PROT.648.00024.A
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Lyme Disease; Healthy

Outcome Measures

Primary Outcomes (1)

• Clinical Performance - Sensitivity

  Diagnostic Sensitivity

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Clinical Performance - Specificity

  Through study completion, an average of 1 year

Study Arms (2)

Sick Cohort

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)

Diagnostic Test: Lyme diagnostic assay

Apparently Healthy

Apparently healthy subjects living in an area non-endemic for Lyme disease Apparently healthy subjects living in an area endemic for Lyme disease

Diagnostic Test: Lyme diagnostic assay

Interventions

Lyme diagnostic assay DIAGNOSTIC_TEST

Serological and immunoresponse assay

Apparently Healthy; Sick Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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

You may not qualify if:

• Subjects unable to provide informed consent.
• Healthy Subjects
• 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.
• \- ● Subjects unable to provide informed consent
• 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

Sponsors & Collaborators

• DiaSorin Inc.: lead

Study Sites (1)

DiaSorin Inc.

Stillwater, Minnesota, 55082, United States

Location

MeSH Terms

Conditions

Lyme Disease

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 13, 2021
• Study Start: May 3, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (1)