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

NCT02741609 | Terminated

• 1 other identifier: IR-12
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 16

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.

Conditions

Lyme Disease

Keywords

Borrelia; spirochetes; culture; immunostaining

Outcome Measures

Primary Outcomes (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.

  Baseline to 16 weeks

Secondary Outcomes (2)

• 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

Study Arms (1)

Early/Late Stage Lyme disease

EXPERIMENTAL

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

Interventions

Borrelia Diagnostic Test DEVICE

The ALSI BDT is a high-yield in vitro cultivation method for Borrelia burgdorferi from venous whole blood samples.

Early/Late Stage Lyme disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \---

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Laboratory Services, Inc.: lead

Study Sites (16)

Delaware Integrative Medicine

Georgetown, Delaware, 19947, United States

Location

Penobscot Bay Medical Center

Rockport, Maine, 04956, United States

Location

Infectious Disease/The Research Institute

Springfield, Massachusetts, 01105, United States

Location

Birch Tree Healing Arts

Saint Paul, Minnesota, 55114, United States

Location

Mid Hudson Medical Research, PLLC

New Windsor, New York, 12553, United States

Location

Dr. Steven Bock, MD

Rhinebeck, New York, 12572, United States

Location

Dr. Marina Makous

Exton, Pennsylvania, 19341, United States

Location

Detweiler Family Medicine & Associates, PC

Lansdale, Pennsylvania, 19446, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Cumberland Valley Parochial Medical Clinic

Shippensburg, Pennsylvania, 17257, United States

Location

Lyme Center of New England

Cumberland, Rhode Island, 02864, United States

Location

The Miriam Hospital of Infectious Diseases

Providence, Rhode Island, 02906, United States

Location

Virginia Center for Health & Wellness

Aldie, Virginia, 20105, United States

Location

Rockbridge Traditional Medicine

Lexington, Virginia, 24450, United States

Location

Andrs Wellness Consulting

Petersburg, Virginia, 23803, United States

Location

Cardinal Internal Medicine

Woodbridge, Virginia, 22192, United States

Location

MeSH Terms

Conditions

Lyme Disease

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Study Officials

• Jasbir Arora, PhD

  Advanced Laboratory Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 18, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)