A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
NCT ID: NCT02741609
Last Updated: 2018-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
218 participants
INTERVENTIONAL
2016-04-30
2018-01-31
Brief Summary
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This is an 8 month study. Subjects entering the study will have two blood samples collected one month apart if they have early Lyme disease and one blood sample collected if they have late Lyme disease. Subjects who sign an IRB-approved consent form and meet the inclusion and exclusion criteria will be entered into the study. Subjects will be assigned a subject number upon entry and this number will be retained throughout the study.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Early/Late Stage Lyme disease
Have early Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with early stage Lyme disease. Subjects must have a physician-diagnosed erythema migrans (EM) rash and should have systemic symptoms indicative of disseminated infection. Symptoms may include fever, headache, fatigue, myalgias, arthralgias, and stiff neck. Paired acute and convalescent titers will be drawn (first draw at time of initial visit and second draw 4 weeks later). Have late Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with late stage Lyme disease, including but not limited to disseminated rash, arthritis, meningitis, facial palsy, or carditis. Qualified subjects will be administered the Borrelia Diagnostic Test.
Borrelia Diagnostic Test
The ALSI BDT is a high-yield in vitro cultivation method for Borrelia burgdorferi from venous whole blood samples.
Interventions
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Borrelia Diagnostic Test
The ALSI BDT is a high-yield in vitro cultivation method for Borrelia burgdorferi from venous whole blood samples.
Eligibility Criteria
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Inclusion Criteria
2. Male or female subjects who are at least 18 years of age.
3. Subjects are suspected to have early Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with early-stage Lyme disease. Subjects must have a medical practitioner-diagnosed erythema migrans (EM) rash and should have systemic symptoms indicative of disseminated infection. Symptoms may include fever, headache, fatigue, myalgias, arthralgias, and stiff neck. Paired acute and convalescent titers will be drawn (first draw at time of initial visit and second draw 4 weeks later) or,
4. Subjects are suspected to have late Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with late stage Lyme disease, including but not limited to disseminated rash, arthritis, meningitis, facial palsy, or carditis.
5. Subjects must be willing and have the ability to safely have the required quantity of blood drawn for the study at the discretion of the investigator.
6. Subjects must have blood samples freshly collected (no supplemental frozen samples) and the samples must reach ALSI's laboratory on a weekday and within 24 hours of being drawn.
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Exclusion Criteria
2. Exposure to antibiotics of any type during the 6 weeks prior to the initial blood sample collection.
3. Immune deficiency significant enough to render serological tests less reliable.
4. The subject is unwilling or unable to safely have the required quantity of blood drawn for this study.
5. Subjects who are not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation.
6. Subjects that have any other condition or situation which, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study.
7. Subjects that have undergone testing for Lyme disease within the past year.
8. Subjects that have a prior diagnosis of Lyme disease.
18 Years
ALL
No
Sponsors
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Advanced Laboratory Services, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jasbir Arora, PhD
Role: PRINCIPAL_INVESTIGATOR
Advanced Laboratory Services
Locations
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Delaware Integrative Medicine
Georgetown, Delaware, United States
Penobscot Bay Medical Center
Rockport, Maine, United States
Infectious Disease/The Research Institute
Springfield, Massachusetts, United States
Birch Tree Healing Arts
Saint Paul, Minnesota, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States
Dr. Steven Bock, MD
Rhinebeck, New York, United States
Dr. Marina Makous
Exton, Pennsylvania, United States
Detweiler Family Medicine & Associates, PC
Lansdale, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Cumberland Valley Parochial Medical Clinic
Shippensburg, Pennsylvania, United States
Lyme Center of New England
Cumberland, Rhode Island, United States
The Miriam Hospital of Infectious Diseases
Providence, Rhode Island, United States
Virginia Center for Health & Wellness
Aldie, Virginia, United States
Rockbridge Traditional Medicine
Lexington, Virginia, United States
Andrs Wellness Consulting
Petersburg, Virginia, United States
Cardinal Internal Medicine
Woodbridge, Virginia, United States
Countries
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Other Identifiers
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IR-12
Identifier Type: -
Identifier Source: org_study_id
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