Status:
COMPLETED
Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Karius, Inc.
Conditions:
Musculoskeletal Infection
Acute Hematogenous Osteomyelitis
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- 6 months (to ensure adequate blood volume drawn) to 18 years of age.
- 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
- Subjects will be excluded if they have clinical evidence suggesting an alternative diagnosis; inability or unwillingness to consent for the study
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03846804
Start Date
September 1 2019
End Date
June 2 2022
Last Update
December 1 2023
Active Locations (1)
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1
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202