Next Generation Sequencing Detection of Lyme Disease

Completed

• Conditions: Pediatric Infectious Disease; Erythema Migrans; Lyme Disease; Lyme Arthritis; Lyme Carditis; Lyme Disease Meningitis

• Registration Number: NCT03505879
• Lead Sponsor: Stony Brook University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-23
• Study Start: 2018-07-24
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Clinical Research Center; 🇺🇸 Setauket, New York, United States