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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 : October 16, 2019
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 October 16, 2019
Actual Study Start Date July 24, 2018
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 14, 2019)
  • Ability of Next Generation Sequencing to detect Borrelia burgdorferi DNA in blood [ Time Frame: 1 year ]
    To determine if Next Generation Sequencing (NGS) is able to detect Borrelia burgdorferi DNA in the blood of pediatric patients with Lyme disease, including those with erythema migrans (single or multiple), Lyme meningitis, Lyme carditis, Lyme disease facial palsy, and Lyme arthritis
  • NGS detection of Borrelia burgdorferi DNA following antibiotics [ Time Frame: 1 year ]
    To determine if Next Generation Sequencing (NGS) is able to detect Borrelia burgdorferi DNA in the blood of pediatric patients with a multiple erythema migrans rash shortly after the first dose of antibiotics.
Original 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
Change History Complete list of historical versions of study NCT03505879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original 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.
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 Disease
Brief Summary Next Generation Sequencing is capable of sequencing millions of small strands of DNA from a single blood sample, potentially improving its sensitivity compared to PCR testing, which only detects predetermined larger strands of DNA. We will test the ability of NGS to detect Borrelia burgdorferi DNA in the blood of pediatric patients with Lyme disease. We will conduct an observational study of NGS testing on pediatric patients at all stages of Lyme disease. Study involvement will require a single study visit for clinical data collection and blood draw. We will enroll patients at all phases of suspected Lyme disease, collect clinically relevant information, and test for Lyme disease using Next Generation Sequencing and standard Lyme serologic testing. If the patient has multiple erythema migrans, Lyme meningitis, facial nerve palsy, arthritis, or carditis, a B. burgdorferi serum PCR will also be sent. Enrollment and Next Generation Sequencing blood draw will occur before or up to 24 hours after the first dose of antibiotics is administered. We will also study the impact of antibiotics on NGS testing by running the test 6-24 hours after antibiotics are started among a small subset of patients with a multiple erythema migrans rash. Collected data will be analyzed with basic descriptive statistics.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
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 specific Lyme disease syndrome and have been on antibiotics for less than 24 hours prior to blood draw
Condition
  • Lyme Disease
  • Pediatric Infectious Disease
  • Erythema Migrans
  • Lyme Arthritis
  • Lyme Carditis
  • Lyme Disease Meningitis
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 May 31, 2020
Estimated Primary Completion Date May 31, 2020   (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 spent time in a Lyme-endemic area during the previous month
  3. The subject has a suspected Lyme disease infection

Exclusion criteria:

  1. Past infection with Lyme disease
  2. Received oral or IV antibiotics within 1 month prior to presentation Note: Subjects may be enrolled if NGS blood test can be drawn <24 hours after the first dose of Lyme diseasetargeted antibiotics is administered
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 October 2019