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

Stopped early · Not applicable

Conditions studied: Lyme Disease

In brief

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.

Key facts

Study ID

NCT02741609

Run by

Advanced Laboratory Services, Inc.

People needed

218

Starts

2016-04-01

Expected to finish

2018-01-01

Last updated by the study team

2018-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.