Next Generation Sequencing Detection of Lyme Disease
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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. |
ClinicalTrials.gov Identifier: NCT03505879 |
Recruitment Status :
Recruiting
First Posted : April 23, 2018
Last Update Posted : October 16, 2019
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Condition or disease |
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Lyme Disease Pediatric Infectious Disease Erythema Migrans Lyme Arthritis Lyme Carditis Lyme Disease Meningitis |
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 |

- 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.
Biospecimen Retention: Samples With DNA

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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 |
Lyme disease subjects (Cases):
Inclusion criteria:
- Age 1 to <18 years old
- The subject has spent time in a Lyme-endemic area during the previous month
- The subject has a suspected Lyme disease infection
Exclusion criteria:
- Past infection with Lyme disease
- 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

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
Contact: Christy Beneri, DO | (631) 444-7692 | Christy.Beneri@stonybrookmedicine.edu | |
Contact: Andrew Handel, MD | (631) 444-7692 | Andrew.handel@stonybrookmedicine.edu |
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 |
Responsible Party: | Christy Beneri, Assistant Professor of Pediatrics, Stony Brook University |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Next Generation Sequencing |
Communicable Diseases Infection Lyme Disease Erythema Chronicum Migrans Glossitis, Benign Migratory Meningitis Erythema 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 Glossitis Tongue Diseases Mouth Diseases Stomatognathic Diseases |