Next Generation Sequencing Detection of Lyme Disease

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.

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Key information

Conditions

Lyme Disease Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Erythema Migrans Glossitis Glossitis, Benign Migratory Gram-Negative Bacterial Infections Infections Lyme Arthritis Lyme Carditis Lyme Disease Meningitis Mouth Diseases Pediatric Infectious Disease Spirochaetales Infections Stomatognathic Diseases Tick-Borne Diseases Tongue Diseases Vector Borne Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Center

Setauket, New York, 11733-9219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

Karius, Inc.

Registry information

Official study title

Next Generation Sequencing to Detect Borrelia Burgdorferi DNA in the Blood of Pediatric Patients With Lyme Disease

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Apr 23, 2018
Registry last updated: Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed