search
Back to results

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

Primary Purpose

Lyme Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Borrelia Diagnostic Test
Sponsored by
Advanced Laboratory Services, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lyme Disease focused on measuring Borrelia, spirochetes, culture, immunostaining

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Delaware Integrative Medicine
  • Penobscot Bay Medical Center
  • Infectious Disease/The Research Institute
  • Birch Tree Healing Arts
  • Mid Hudson Medical Research, PLLC
  • Dr. Steven Bock, MD
  • Dr. Marina Makous
  • Detweiler Family Medicine & Associates, PC
  • Suburban Research Associates
  • Cumberland Valley Parochial Medical Clinic
  • Lyme Center of New England
  • The Miriam Hospital of Infectious Diseases
  • Virginia Center for Health & Wellness
  • Rockbridge Traditional Medicine
  • Andrs Wellness Consulting
  • Cardinal Internal Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Early/Late Stage Lyme disease

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Diagnostic accuracy of ALSI culture for early-onset presentation of Lyme disease, as measured by positive and negative predictive value.
Diagnostic accuracy of ALSI culture for late-onset presentation of Lyme disease, as measured by positive and negative predictive value.

Full Information

First Posted
April 6, 2016
Last Updated
January 15, 2018
Sponsor
Advanced Laboratory Services, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02741609
Brief Title
A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
Acronym
ALSIBDT
Official Title
A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor lack of funding
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Laboratory Services, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease
Keywords
Borrelia, spirochetes, culture, immunostaining

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early/Late Stage Lyme disease
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Borrelia Diagnostic Test
Intervention Description
The ALSI BDT is a high-yield in vitro cultivation method for Borrelia burgdorferi from venous whole blood samples.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must provide written informed consent prior to the conduct of any study-related procedures. Male or female subjects who are at least 18 years of age. 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, 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. 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. 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: Early Lyme disease: Subjects without an EM rash or do not have symptoms recognized as being associated with Lyme disease. Exposure to antibiotics of any type during the 6 weeks prior to the initial blood sample collection. Immune deficiency significant enough to render serological tests less reliable. The subject is unwilling or unable to safely have the required quantity of blood drawn for this study. 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. 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. Subjects that have undergone testing for Lyme disease within the past year. Subjects that have a prior diagnosis of Lyme disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasbir Arora, PhD
Organizational Affiliation
Advanced Laboratory Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Delaware Integrative Medicine
City
Georgetown
State/Province
Delaware
ZIP/Postal Code
19947
Country
United States
Facility Name
Penobscot Bay Medical Center
City
Rockport
State/Province
Maine
ZIP/Postal Code
04956
Country
United States
Facility Name
Infectious Disease/The Research Institute
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
Country
United States
Facility Name
Birch Tree Healing Arts
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Mid Hudson Medical Research, PLLC
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Dr. Steven Bock, MD
City
Rhinebeck
State/Province
New York
ZIP/Postal Code
12572
Country
United States
Facility Name
Dr. Marina Makous
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
Detweiler Family Medicine & Associates, PC
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Cumberland Valley Parochial Medical Clinic
City
Shippensburg
State/Province
Pennsylvania
ZIP/Postal Code
17257
Country
United States
Facility Name
Lyme Center of New England
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
The Miriam Hospital of Infectious Diseases
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Virginia Center for Health & Wellness
City
Aldie
State/Province
Virginia
ZIP/Postal Code
20105
Country
United States
Facility Name
Rockbridge Traditional Medicine
City
Lexington
State/Province
Virginia
ZIP/Postal Code
24450
Country
United States
Facility Name
Andrs Wellness Consulting
City
Petersburg
State/Province
Virginia
ZIP/Postal Code
23803
Country
United States
Facility Name
Cardinal Internal Medicine
City
Woodbridge
State/Province
Virginia
ZIP/Postal Code
22192
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs