Next Generation Sequencing Detection of Lyme Disease

NCT03505879 | Completed

• 1 other identifier: 1205731-1
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Next Generation Sequencing

Outcome Measures

Primary Outcomes (2)

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

  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

  1 year

• NGS detection of Borrelia burgdorferi DNA following antibiotics

  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.

  1 year

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

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

Sponsors & Collaborators

• Stony Brook University: lead
• Karius, Inc.: collaborator

Study Sites (1)

Clinical Research Center

Setauket, New York, 11733-9219, United States

Location

Related Publications (7)

• Schwartz AM, Hinckley AF, Mead PS, Hook SA, Kugeler KJ. Surveillance for Lyme Disease - United States, 2008-2015. MMWR Surveill Summ. 2017 Nov 10;66(22):1-12. doi: 10.15585/mmwr.ss6622a1.

  PMID: 29120995 BACKGROUND

• Theel ES. The Past, Present, and (Possible) Future of Serologic Testing for Lyme Disease. J Clin Microbiol. 2016 May;54(5):1191-6. doi: 10.1128/JCM.03394-15. Epub 2016 Feb 10.

  PMID: 26865690 BACKGROUND

• Aguero-Rosenfeld ME, Wang G, Schwartz I, Wormser GP. Diagnosis of lyme borreliosis. Clin Microbiol Rev. 2005 Jul;18(3):484-509. doi: 10.1128/CMR.18.3.484-509.2005.

  PMID: 16020686 BACKGROUND

• Babady NE, Sloan LM, Vetter EA, Patel R, Binnicker MJ. Percent positive rate of Lyme real-time polymerase chain reaction in blood, cerebrospinal fluid, synovial fluid, and tissue. Diagn Microbiol Infect Dis. 2008 Dec;62(4):464-6. doi: 10.1016/j.diagmicrobio.2008.08.016. Epub 2008 Oct 22.

  PMID: 18947959 BACKGROUND

• Kalish RA, McHugh G, Granquist J, Shea B, Ruthazer R, Steere AC. Persistence of immunoglobulin M or immunoglobulin G antibody responses to Borrelia burgdorferi 10-20 years after active Lyme disease. Clin Infect Dis. 2001 Sep 15;33(6):780-5. doi: 10.1086/322669. Epub 2001 Aug 10.

  PMID: 11512082 BACKGROUND

• da Fonseca AJ, Galvao RS, Miranda AE, Ferreira LC, Chen Z. Comparison of three human papillomavirus DNA detection methods: Next generation sequencing, multiplex-PCR and nested-PCR followed by Sanger based sequencing. J Med Virol. 2016 May;88(5):888-94. doi: 10.1002/jmv.24413. Epub 2015 Nov 6.

  PMID: 26496186 BACKGROUND

• 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.

  PMID: 27704003 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples for detection of infectious pathogens by next generation sequencing

MeSH Terms

Conditions

Lyme Disease; Glossitis, Benign Migratory

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Glossitis; Tongue Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 23, 2018
• Study Start: July 24, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

US (1)