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

NCT03846804 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-12-01

Study results available
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Summary

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).

Conditions

  • Musculoskeletal Infection
  • Acute Hematogenous Osteomyelitis
  • Septic Arthritis
  • Osteomyelitis
  • Pyomyositis

Interventions

DIAGNOSTIC_TEST

Karius Test

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

Sponsors & Collaborators

  • Karius, Inc.

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Jack G Schneider, MD · Indiana University School of Medicine - Pediatrics

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-06-02
Completion
2022-06-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03846804 on ClinicalTrials.gov