Next Generation Sequencing Detection of Lyme Disease

Completed

Conditions studied: Lyme Disease, Pediatric Infectious Disease, Erythema Migrans, Lyme Arthritis, Lyme Carditis, Lyme Disease Meningitis

In brief

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.

Key facts

Study ID

NCT03505879

Run by

Stony Brook University

People needed

15

Starts

2018-07-24

Expected to finish

2020-05-31

Last updated by the study team

2022-02-25

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Center — Setauket, New York, United States

Full record on ClinicalTrials.gov

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