CompletedNot Applicable

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

United States38 participantsStarted 2019-09-01

Plain-language 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).

Who can participate

Age range6 Months – 18 Years

SexALL

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Inclusion criteria

✓. 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).

What they're measuring

Number of Participants With a Pathogen Identified by the Initial Karius Test (IP1) and Standard Culture Methods

Timeframe: Inpatient Sample 1 (IP1) - Within 48 hours of admission

Number of Participants With a Pathogen Identified by the Karius Test (at Time Point IP2) and Standard Culture Methods

Timeframe: Inpatient Sample 2 (IP2) - Within 48 hours of the initial sample

Trial details

NCT IDNCT03846804

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-02

Results submitted2023-08-02

View on ClinicalTrials.gov More Musculoskeletal Infection trials