Clinical trial NCT02741609: A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
Official title: A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lyme Disease
Keywords: Borrelia
spirochetes
culture
immunostaining
Lead sponsor: Advanced Laboratory Services, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-18
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline to 16 weeks
Secondary outcomes:
measure: Diagnostic accuracy of ALSI culture for early-onset presentation of Lyme disease, as measured by positive and negative predictive value.
timeFrame: Baseline to 16 weeks
measure: Diagnostic accuracy of ALSI culture for late-onset presentation of Lyme disease, as measured by positive and negative predictive value.
timeFrame: Baseline to 16 weeks
Other outcomes:
Locations:
city: Georgetown
country: United States
facility: Delaware Integrative Medicine
state: Delaware
city: Rockport
country: United States
facility: Penobscot Bay Medical Center
state: Maine
city: Springfield
country: United States
facility: Infectious Disease/The Research Institute
state: Massachusetts
city: Saint Paul
country: United States
facility: Birch Tree Healing Arts
state: Minnesota
city: New Windsor
country: United States
facility: Mid Hudson Medical Research, PLLC
state: New York
city: Rhinebeck
country: United States
facility: Dr. Steven Bock, MD
state: New York
city: Exton
country: United States
facility: Dr. Marina Makous
state: Pennsylvania
city: Lansdale
country: United States
facility: Detweiler Family Medicine & Associates, PC
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Shippensburg
country: United States
facility: Cumberland Valley Parochial Medical Clinic
state: Pennsylvania
city: Cumberland
country: United States
facility: Lyme Center of New England
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital of Infectious Diseases
state: Rhode Island
city: Aldie
country: United States
facility: Virginia Center for Health & Wellness
state: Virginia
city: Lexington
country: United States
facility: Rockbridge Traditional Medicine
state: Virginia
city: Petersburg
country: United States
facility: Andrs Wellness Consulting
state: Virginia
city: Woodbridge
country: United States
facility: Cardinal Internal Medicine
state: Virginia
Study officials:
affiliation: Advanced Laboratory Services
name: Jasbir Arora, PhD
role: PRINCIPAL_INVESTIGATOR
References: