A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
Please refer to this study by its ClinicalTrials.gov identifier: NCT02741609
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 Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2016|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
|Ages Eligible for Study:||18 Years and older (Adult, Senior)|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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.
- 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) or,
- 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.
- 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.
Contacts and Locations
|Contact: Phyllis A Mast, MAfirstname.lastname@example.org|
|United States, Delaware|
|Delaware Integrative Medicine||Recruiting|
|Georgetown, Delaware, United States, 19947|
|Contact: Henry Childers IV, MD 302-258-8853|
|United States, Maine|
|Penobscot Bay Medical Center||Recruiting|
|Rockport, Maine, United States, 04956|
|Contact: Mark Eggena, MD 207-593-5800|
|United States, Maryland|
|IRC Clinics, Inc.||Recruiting|
|Towson, Maryland, United States, 21204|
|Contact: Amanda Hazelton|
|Principal Investigator: Alberto Yataco, MD|
|United States, Pennsylvania|
|Detweiler Family Medicine & Associates, PC||Recruiting|
|Lansdale, Pennsylvania, United States, 19446|
|Contact: Jennifer Adams, LPN|
|Principal Investigator: Evan Kessler, DO|
|Suburban Research Associates||Recruiting|
|Media, Pennsylvania, United States, 19063|
|Contact: Avrom Brown, MD|
|United States, Rhode Island|
|Lyme Center of New England||Recruiting|
|Cumberland, Rhode Island, United States, 02864|
|Contact: Susan Neuber, NP 401-334-5963|
|The Miriam Hospital of Infectious Diseases||Recruiting|
|Providence, Rhode Island, United States, 02906|
|Contact: Rebecca Reece, MD|
|Contact: Timothy Flanigan, MD|
|United States, Virginia|
|Virginia Center for Health & Wellness||Recruiting|
|Aldie, Virginia, United States, 20105|
|Contact: Andrew Heyman, MD 703-327-2434|
|Cardinal Internal Medicine||Recruiting|
|Woodbridge, Virginia, United States, 22192|
|Contact: Atoussa Farough, MD 703-897-4700|
|Principal Investigator:||Timothy R Schwartz, PhD||Advanced Laboratory Services|