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

Lyme Disease Clinical Trial

— ALSIBDT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02741609
• Other study ID #: IR-12
• Status: Terminated
• Phase: N/A
• First received: April 6, 2016
• Last updated: January 15, 2018
• Start date: April 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Advanced Laboratory Services, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 218
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lyme Disease

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Center for Health & Wellness	Aldie	Virginia
United States	Lyme Center of New England	Cumberland	Rhode Island
United States	Dr. Marina Makous	Exton	Pennsylvania
United States	Delaware Integrative Medicine	Georgetown	Delaware
United States	Detweiler Family Medicine & Associates, PC	Lansdale	Pennsylvania
United States	Rockbridge Traditional Medicine	Lexington	Virginia
United States	Suburban Research Associates	Media	Pennsylvania
United States	Mid Hudson Medical Research, PLLC	New Windsor	New York
United States	Andrs Wellness Consulting	Petersburg	Virginia
United States	The Miriam Hospital of Infectious Diseases	Providence	Rhode Island
United States	Dr. Steven Bock, MD	Rhinebeck	New York
United States	Penobscot Bay Medical Center	Rockport	Maine
United States	Birch Tree Healing Arts	Saint Paul	Minnesota
United States	Cumberland Valley Parochial Medical Clinic	Shippensburg	Pennsylvania
United States	Infectious Disease/The Research Institute	Springfield	Massachusetts
United States	Cardinal Internal Medicine	Woodbridge	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Laboratory Services, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnostic accuracy of ALSI culture for early-onset presentation of Lyme disease, as measured by positive and negative predictive value.		Baseline to 16 weeks
Secondary	Diagnostic accuracy of ALSI culture for late-onset presentation of Lyme disease, as measured by positive and negative predictive value.		Baseline to 16 weeks