Next Generation Sequencing Detection of Lyme Disease

Sponsor

Stony Brook University (Other)

Overall Status

Completed

CT.gov ID

NCT03505879

Collaborator

Karius, Inc. (Industry)

Enrollment

Location

22.2

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Lyme Disease Pediatric Infectious Disease Erythema Migrans Lyme Arthritis Lyme Carditis Lyme Disease Meningitis

Study Design

Study Type:

Observational

Actual Enrollment :

15 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 :

Jul 24, 2018

Actual Primary Completion Date :

May 31, 2020

Actual Study Completion Date :

May 31, 2020

Outcome Measures

Primary Outcome Measures

Ability of Next Generation Sequencing to detect Borrelia burgdorferi DNA in blood [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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