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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

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.

Condition or disease
Lyme Disease Pediatric Infectious Disorder Erythema Migrans

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Next Generation Sequencing to Detect Borrelia Burgdorferi DNA in the Blood of Pediatric Patients With Lyme-Related Erythema Migrans
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 1, 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: 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).

  2. 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


Secondary Outcome Measures :
  1. 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.


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


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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 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.

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

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 ClinicalTrials.gov identifier (NCT number): NCT03505879


Contacts
Contact: Christy Beneri, DO (631) 444-7692 Christy.Beneri@stonybrookmedicine.edu
Contact: Andrew Handel, MD (631) 444-7692 Andrew.handel@stonybrookmedicine.edu

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

Publications:

Responsible Party: Christy Beneri, Assistant Professor of Pediatrics, Stony Brook University
ClinicalTrials.gov Identifier: NCT03505879     History of Changes
Other Study ID Numbers: 1205731-1
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

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:
Lyme Disease
Skin Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Erythema
Communicable Diseases
Infection
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases