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A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease (ALSIBDT)

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ClinicalTrials.gov Identifier: NCT02741609
Recruitment Status : Terminated (Sponsor lack of funding)
First Posted : April 18, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Advanced Laboratory Services, Inc.

Brief Summary:

This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing Borrelia spirochetes from human serum in subjects with early or late Lyme disease.

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.


Condition or disease Intervention/treatment Phase
Lyme Disease Device: Borrelia Diagnostic Test Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Arm Intervention/treatment
Experimental: 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.
Device: Borrelia Diagnostic Test
The ALSI BDT is a high-yield in vitro cultivation method for Borrelia burgdorferi from venous whole blood samples.




Primary Outcome Measures :
  1. Diagnostic accuracy of the Advanced Laboratory Services, Inc. (ALSI) Borrelia Diagnostic Test (BDT) culture, for positive and negative predictive value, as compared to conventional microbiological methods. [ Time Frame: Baseline to 16 weeks ]

Secondary Outcome Measures :
  1. Diagnostic accuracy of ALSI culture for early-onset presentation of Lyme disease, as measured by positive and negative predictive value. [ Time Frame: Baseline to 16 weeks ]
  2. Diagnostic accuracy of ALSI culture for late-onset presentation of Lyme disease, as measured by positive and negative predictive value. [ Time Frame: Baseline to 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must provide written informed consent prior to the conduct of any study-related procedures.
  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.

Exclusion Criteria:

  1. Early Lyme disease: Subjects without an EM rash or do not have symptoms recognized as being associated with Lyme disease.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741609


Locations
United States, Delaware
Delaware Integrative Medicine
Georgetown, Delaware, United States, 19947
United States, Maine
Penobscot Bay Medical Center
Rockport, Maine, United States, 04956
United States, Massachusetts
Infectious Disease/The Research Institute
Springfield, Massachusetts, United States, 01105
United States, Minnesota
Birch Tree Healing Arts
Saint Paul, Minnesota, United States, 55114
United States, New York
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States, 12553
Dr. Steven Bock, MD
Rhinebeck, New York, United States, 12572
United States, Pennsylvania
Dr. Marina Makous
Exton, Pennsylvania, United States, 19341
Detweiler Family Medicine & Associates, PC
Lansdale, Pennsylvania, United States, 19446
Suburban Research Associates
Media, Pennsylvania, United States, 19063
Cumberland Valley Parochial Medical Clinic
Shippensburg, Pennsylvania, United States, 17257
United States, Rhode Island
Lyme Center of New England
Cumberland, Rhode Island, United States, 02864
The Miriam Hospital of Infectious Diseases
Providence, Rhode Island, United States, 02906
United States, Virginia
Virginia Center for Health & Wellness
Aldie, Virginia, United States, 20105
Rockbridge Traditional Medicine
Lexington, Virginia, United States, 24450
Andrs Wellness Consulting
Petersburg, Virginia, United States, 23803
Cardinal Internal Medicine
Woodbridge, Virginia, United States, 22192
Sponsors and Collaborators
Advanced Laboratory Services, Inc.
Investigators
Principal Investigator: Jasbir Arora, PhD Advanced Laboratory Services

Responsible Party: Advanced Laboratory Services, Inc.
ClinicalTrials.gov Identifier: NCT02741609     History of Changes
Other Study ID Numbers: IR-12
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Advanced Laboratory Services, Inc.:
Borrelia
spirochetes
culture
immunostaining

Additional relevant MeSH terms:
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections