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

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.

Study Overview

• Status: Terminated
• Conditions: Lyme Disease
• Intervention / Treatment: Device: Borrelia Diagnostic Test

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Baseline to 16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy of ALSI culture for early-onset presentation of Lyme disease, as measured by positive and negative predictive value.	Baseline to 16 weeks
Diagnostic accuracy of ALSI culture for late-onset presentation of Lyme disease, as measured by positive and negative predictive value.	Baseline to 16 weeks

Collaborators and Investigators

• Sponsor: Advanced Laboratory Services, Inc.
• Investigators: Principal Investigator: Jasbir Arora, PhD, Advanced Laboratory Services

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 18, 2016

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 15, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Borrelia; spirochetes; culture; immunostaining
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Tick-Borne Diseases; Borrelia Infections; Spirochaetales Infections; Lyme Disease
• Other Study ID Numbers: IR-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No