Clinical trial NCT03505879: Next Generation Sequencing Detection of Lyme Disease
Official title: Next Generation Sequencing to Detect Borrelia Burgdorferi DNA in the Blood of Pediatric Patients With Lyme Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lyme Disease
Pediatric Infectious Disease
Erythema Migrans
Lyme Arthritis
Lyme Carditis
Lyme Disease Meningitis
Keywords: Next Generation Sequencing
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Karius, Inc.
First posted: 2018-04-23
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases will include pediatric patients age 1 to \<18 years old who currently have a specific Lyme disease syndrome and have been on antibiotics for less than 24 hours prior to blood draw

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.


Eligibility 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

Primary outcomes:
measure: Ability of Next Generation Sequencing to detect Borrelia burgdorferi DNA in blood
timeFrame: 1 year
measure: NGS detection of Borrelia burgdorferi DNA following antibiotics
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Setauket
country: United States
facility: Clinical Research Center
state: New York
Study officials:
References:
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citation: Abril MK, Barnett AS, Wegermann K, Fountain E, Strand A, Heyman BM, Blough BA, Swaminathan AC, Sharma-Kuinkel B, Ruffin F, Alexander BD, McCall CM, Costa SF, Arcasoy MO, Hong DK, Blauwkamp TA, Kertesz M, Fowler VG Jr, Kraft BD. Diagnosis of Capnocytophaga canimorsus Sepsis by Whole-Genome Next-Generation Sequencing. Open Forum Infect Dis. 2016 Jul 12;3(3):ofw144. doi: 10.1093/ofid/ofw144. eCollection 2016 Sep.