N/A
Completed N=38
Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections
Musculoskeletal Infection · Acute Hematogenous Osteomyelitis · Septic Arthritis · Osteomyelitis
Source: ClinicalTrials.gov NCT03846804 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Number of Participants With a Pathogen Identified by the Initial Karius Test (IP1) and Standard Culture Methods — 23; 26; 15 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Pathogen Identified by the Initial Karius Test (IP1) and Standard Culture Methods |
23; 26; 15 | — |
| PRIMARY Number of Participants With a Pathogen Identified by the Karius Test (at Time Point IP2) and Standard Culture Methods |
10; 3; 5 | — |
| SECONDARY Microbial Cell Free DNA Level (cfDNA) in Molecules Per Microliter (MPM) |
408; 322 | 0.36 |
| SECONDARY Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point IP1 |
0.43; 0.36; 0.33 | — |
| SECONDARY Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point IP2 |
0.79 | — |
| SECONDARY Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Timepoint IP3 |
1.0 | — |
| SECONDARY Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point IP4 |
NA | — |
| SECONDARY Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point OP1 |
NA | — |
| SECONDARY Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point OP2 |
NA | — |
| SECONDARY Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point OP3 |
— | — |
Eligibility Criteria
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).
Exclusion Criteria
- Subjects will be excluded if they have clinical evidence suggesting an alternative diagnosis; inability or unwillingness to consent for the study
Data sourced from ClinicalTrials.gov (NCT03846804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.