Clinical Trial: A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
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.
Detailed Summary:
Sponsor: Advanced Laboratory Services, Inc.
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
- 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 ]
Original Secondary Outcome: Same as current
Information By: Advanced Laboratory Services, Inc.
Dates:
Date Received: April 6, 2016
Date Started: April 2016
Date Completion: December 2017
Last Updated: May 8, 2017
Last Verified: May 2017
