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Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections

NCT ID: NCT03846804

Last Updated: 2023-12-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-06-02

Brief Summary

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The purpose of this study is to evaluate the use of a blood test: Karius® plasma-based next-generation sequencing test (Karius Test), to see if we can detect and measure the infection causing agent in children with musculoskeletal infections (MSKI).

Detailed Description

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children admitted to Riley Hospital for Children (RHC) with musculoskeletal infections (osteomyelitis, septic arthritis, or pyomyositis) over a 12-month period will be prospectively enrolled. Eligible subjects will be identified by referral from the infectious diseases and orthopedic services at RHC. Blood samples will be obtained on the day of admission (within 48hrs), and 24 hours after the admission sample for real-time NGS (next-generation sequencing) testing at Karius Laboratory (Redwood City, CA). If a pathogen is identified by NGS, in either of the first two samples, subsequent samples will be sent every 48-72 hours while inpatient, and then collected every 1-2 weeks after hospital discharge, while being treated for MSKI (maximum 3 follow-up samples). If both of the initial inpatient NGS samples are negative, no further samples will be sent for NGS. Pathogen identification by NGS will be compared to standard cultures methods, and quantitative cfDNA (cell-free DNA) will be evaluated over time.

Conditions

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Musculoskeletal Infection Acute Hematogenous Osteomyelitis Septic Arthritis Osteomyelitis Pyomyositis

Keywords

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infection plasma based next generation sequencing blood culture tissue culture joint fluid culture pathogen identification

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Karius Test

Participants will have additional blood drawn for the purposes of analysis with the Karius test.

Group Type EXPERIMENTAL

Karius Test

Intervention Type DIAGNOSTIC_TEST

Next-generation sequencing of blood and synovial fluid samples for pathogen identification in children with musculoskeletal infections

Interventions

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Karius Test

Next-generation sequencing of blood and synovial fluid samples for pathogen identification in children with musculoskeletal infections

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 6 months (to ensure adequate blood volume drawn) to 18 years of age.
2. Strong clinical suspicion of MSKI as evidenced by fever, osteoarticular pain (e.g. tenderness to palpation of a joint, bone pain, or refusal to bear weight); and elevated ESR (erythrocyte sedimentation rate) or CRP (C-reactive protein).

Exclusion Criteria

* Subjects will be excluded if they have clinical evidence suggesting an alternative diagnosis; inability or unwillingness to consent for the study
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karius, Inc.

INDUSTRY

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Jack Schneider

Assistant Professor of Clinical Medicine and Clinical Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jack G Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine - Pediatrics

Locations

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Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1901296571

Identifier Type: -

Identifier Source: org_study_id