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Next Generation Sequencing Detection of Lyme Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03505879
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : October 16, 2019
Karius, Inc.
Information provided by (Responsible Party):
Christy Beneri, Stony Brook University

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.

Condition or disease
Lyme Disease Pediatric Infectious Disease Erythema Migrans Lyme Arthritis Lyme Carditis Lyme Disease Meningitis

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Next Generation Sequencing to Detect Borrelia Burgdorferi DNA in the Blood of Pediatric Patients With Lyme Disease
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Primary Outcome Measures :
  1. 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

  2. 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.

Biospecimen Retention:   Samples With DNA
Whole blood samples for detection of infectious pathogens by next generation sequencing

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03505879

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Contact: Christy Beneri, DO (631) 444-7692
Contact: Andrew Handel, MD (631) 444-7692

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United States, New York
Clinical Research Center Recruiting
Setauket, New York, United States, 11733-9219
Contact: Wendy Mattias    631-444-6900   
Contact: Erin Infanzon    631-444-8832   
Principal Investigator: Christy A Beneri         
Sub-Investigator: Andrew Handel         
Sponsors and Collaborators
Stony Brook University
Karius, Inc.

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Responsible Party: Christy Beneri, Assistant Professor of Pediatrics, Stony Brook University Identifier: NCT03505879    
Other Study ID Numbers: 1205731-1
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christy Beneri, Stony Brook University:
Next Generation Sequencing
Additional relevant MeSH terms:
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Communicable Diseases
Lyme Disease
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Central Nervous System Diseases
Nervous System Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Skin Diseases
Skin Manifestations
Borrelia Infections
Tick-Borne Diseases
Spirochaetales Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases