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Next Generation Sequencing Detection of Lyme Disease

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ClinicalTrials.gov Identifier: NCT03505879
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Karius, Inc.
Information provided by (Responsible Party):
Christy Beneri, Stony Brook University

Tracking Information
First Submitted Date April 13, 2018
First Posted Date April 23, 2018
Last Update Posted Date September 7, 2018
Actual Study Start Date July 24, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2018)
  • Ability of Next Generation Sequencing to detect Borrelia burgdorferi DNA in blood [ Time Frame: 5 months ]
    To determine if Next Generation Sequencing (NGS) is able to detect Borrelia burgdorferi DNA in the blood of pediatric patients with clinically-diagnosed erythema migrans (EM).
  • NGS detection of Borrelia burgdorferi DNA in blood compared to serology [ Time Frame: 5 months ]
    To compare the ability to detect Borrelia burgdorferi infection among pediatric patients with an erythema migrans using NGS versus serology
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03505879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 13, 2018)
Changes in NGS detection of Borrelia burgdorferi DNA in blood over time [ Time Frame: 5 months ]
To determine if the detection of Borrelia burgdorferi DNA in pediatric patients with an EM changes over time after appropriate antibiotic treatment of Lyme disease.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Next Generation Sequencing Detection of Lyme Disease
Official Title Next Generation Sequencing to Detect Borrelia Burgdorferi DNA in the Blood of Pediatric Patients With Lyme-Related Erythema Migrans
Brief Summary Next Generation Sequencing is able to sequence all DNA detected in a sample, including short strands. This differs from PCR testing, which uses pre-determined DNA primers to detect a limited number of specific, often large, strands of DNA. The investigators will test the ability of NGS to detect Borrelia burgdorferi DNA in the blood of study participants with an erythema migrans rash. This study will compare 20 study participants with the EM rash (cases) to 10 healthy study participants without an EM rash (controls). The investigators will collect clinically relevant information and send both currently used Lyme testing and Next Generation Sequencing in both the cases and controls. The case participants will then have two requested (but not required) follow up appointments at 1-3 weeks and 2-3 months later to obtain updated clinical information and send repeat NGS testing. The investigators will then conduct basic descriptive statistics on the results to determine if NGS is capable of detecting Lyme DNA during the acute phase of infection.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood samples for detection of infectious pathogens by next generation sequencing
Sampling Method Non-Probability Sample
Study Population

Cases will include pediatric patients age 1 to <18 years old who currently have a rash consisting of single of multiple erythema migrans and have not previously had Lyme disease.

Controls will include pediatric patients age 1 to <18 years old who are currently healthy with no signs or symptoms of Lyme disease and have not previously had Lyme disease.

Condition
  • Lyme Disease
  • Pediatric Infectious Disorder
  • Erythema Migrans
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 13, 2018)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Lyme disease subjects (Cases):

Inclusion criteria:

  1. Age 1 to <18 years old
  2. The subject has a rash consistent with either a single or multiple erythema migrans
  3. The subject has spent time in a Lyme-endemic area during the previous month

Exclusion criteria:

  1. Past infection with Lyme disease
  2. Received oral or IV antibiotics within 1 month prior to presentation

Healthy subjects (Controls):

Inclusion criteria:

  1. Age 1 to <18 years old
  2. Seen at Stony Brook General Pediatric clinic for a Well Child Exam
  3. The subject has spent time in a Lyme-endemic area during the previous month

Exclusion Criteria

  1. Past infection with Lyme disease
  2. Current symptoms of Lyme disease (erythema migrans, persistent headaches, neck stiffness, Bell's palsy, palpitations, shortness of breath, joint swelling)
  3. Current symptoms concerning for infection other than Lyme disease
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Christy Beneri, DO (631) 444-7692 Christy.Beneri@stonybrookmedicine.edu
Contact: Andrew Handel, MD (631) 444-7692 Andrew.handel@stonybrookmedicine.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03505879
Other Study ID Numbers 1205731-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Christy Beneri, Stony Brook University
Study Sponsor Stony Brook University
Collaborators Karius, Inc.
Investigators Not Provided
PRS Account Stony Brook University
Verification Date September 2018