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

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ClinicalTrials.gov Identifier: NCT02741609
Recruitment Status : Terminated (Sponsor lack of funding)
First Posted : April 18, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Advanced Laboratory Services, Inc.

Tracking Information
First Submitted Date  ICMJE April 6, 2016
First Posted Date  ICMJE April 18, 2016
Last Update Posted Date January 17, 2018
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02741609 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Lyme Disease
Intervention  ICMJE Device: Borrelia Diagnostic Test
The ALSI BDT is a high-yield in vitro cultivation method for Borrelia burgdorferi from venous whole blood samples.
Study Arms  ICMJE Experimental: Early/Late Stage Lyme disease
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). 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. Qualified subjects will be administered the Borrelia Diagnostic Test.
Intervention: Device: Borrelia Diagnostic Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 15, 2018)
218
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
300
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02741609
Other Study ID Numbers  ICMJE IR-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Advanced Laboratory Services, Inc.
Study Sponsor  ICMJE Advanced Laboratory Services, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jasbir Arora, PhD Advanced Laboratory Services
PRS Account Advanced Laboratory Services, Inc.
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP