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Advanced Laboratory Services Borrelia Test Eval

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

This study is currently recruiting participants. 
Verified July 2016 by Advanced Laboratory Services, Inc.


Please refer to this study by its ClinicalTrials.gov identifier: NCT02741609

https://clinicaltrials.gov/ct2/show/study/NCT02741609

Purpose

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.


Study Type: Interventional
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


Further study details as provided by Advanced Laboratory Services, Inc.:


Primary Outcome Measures:

  • 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 ]


Secondary Outcome Measures:

  • 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 ]


Estimated Enrollment: 300
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)

Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. 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,
  4. 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.


Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Contacts
Contact: Phyllis A Mast, MA 484-494-5157 pmast@innovative-cro.com


Locations
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      
Sponsors and Collaborators
Advanced Laboratory Services, Inc.
Investigators
Principal Investigator: Timothy R Schwartz, PhD Advanced Laboratory Services


Please refer to this study by its ClinicalTrials.gov identifier: NCT02741609


https://clinicaltrials.gov/ct2/show/study/NCT02741609