NCT03846804

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Karius Test	Next-generation sequencing of blood and synovial fluid samples for pathogen identification in children with musculoskeletal infections

Timeline

• Start date: 2019-09-01
• Primary completion: 2022-06-02
• Completion: 2022-06-02
• First posted: 2019-02-20
• Last updated: 2023-12-01
• Results posted: 2023-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study