Next Generation Sequencing Detection of Lyme Disease

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03505879

Enrollment

Registered

2018-04-23

Start date

2018-07-24

Completion date

2020-05-31

Last updated

2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erythema Migrans, Lyme Arthritis, Lyme Carditis, Lyme Disease, Lyme Disease Meningitis, Pediatric Infectious Disease

Keywords

Next Generation Sequencing

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

Lyme disease subjects (Cases): Inclusion criteria: 1. Age 1 to \<18 years old 2. The subject has spent time in a Lyme-endemic area during the previous month 3. The subject has a suspected Lyme disease infection

Exclusion criteria

1. Past infection with Lyme disease 2. 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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results