Next Generation Sequencing Detection of Lyme Disease
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ClinicalTrials.gov Identifier: NCT03505879 |
Recruitment Status :
Recruiting
First Posted : April 23, 2018
Last Update Posted : October 16, 2019
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Sponsor:
Stony Brook University
Collaborator:
Karius, Inc.
Information provided by (Responsible Party):
Christy Beneri, Stony Brook University
Tracking Information | |||||||||
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First Submitted Date | April 13, 2018 | ||||||||
First Posted Date | April 23, 2018 | ||||||||
Last Update Posted Date | October 16, 2019 | ||||||||
Actual Study Start Date | July 24, 2018 | ||||||||
Estimated Primary Completion Date | May 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||
Original Secondary Outcome Measures |
Changes in NGS detection of Borrelia burgdorferi DNA in blood over time [ Time Frame: 5 months ] To determine if the detection of Borrelia burgdorferi DNA in pediatric patients with an EM changes over time after appropriate antibiotic treatment of Lyme disease.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | 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 | ||||||||
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 Provided | ||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples With DNA Description: Whole blood samples for detection of infectious pathogens by next generation sequencing
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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 | ||||||||
Condition |
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Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Not Provided | ||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
30 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | May 31, 2020 | ||||||||
Estimated Primary Completion Date | May 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Lyme disease subjects (Cases): Inclusion criteria:
Exclusion criteria:
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Sex/Gender |
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Ages | 1 Year to 17 Years (Child) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts |
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Listed Location Countries | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03505879 | ||||||||
Other Study ID Numbers | 1205731-1 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | Christy Beneri, Stony Brook University | ||||||||
Study Sponsor | Stony Brook University | ||||||||
Collaborators | Karius, Inc. | ||||||||
Investigators | Not Provided | ||||||||
PRS Account | Stony Brook University | ||||||||
Verification Date | October 2019 |