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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05041595
Other study ID # PROT.648.00024.A
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 3, 2021
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source DiaSorin Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 450
Est. completion date December 31, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Lyme diagnostic assay
Serological and immunoresponse assay

Locations

Country Name City State
United States DiaSorin Inc. Stillwater Minnesota

Sponsors (1)

Lead Sponsor Collaborator
DiaSorin Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Performance - Sensitivity Diagnostic Sensitivity Through study completion, an average of 1 year
Secondary Clinical Performance - Specificity Diagnostic Specificity Through study completion, an average of 1 year
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