Plasma-Based Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Number of Participants With a Pathogen Identified by the Initial Karius Test (IP1) and Standard Culture Methods
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Subjects will be excluded if they have clinical evidence suggesting an alternative diagnosis; inability or unwillingness to consent for the study
研究组 & 干预措施
Karius Test
Participants will have additional blood drawn for the purposes of analysis with the Karius test.
干预措施: Karius Test (Diagnostic Test)
结局指标
主要结局
Number of Participants With a Pathogen Identified by the Initial Karius Test (IP1) and Standard Culture Methods
时间窗: Inpatient Sample 1 (IP1) - Within 48 hours of admission
We evaluated the total number of participants that had a pathogen identified by the initial (IP1) Karius Test ("positive Karius Test"). We compared the results of the Karius Test to cultures (gold standard) for each participant. Karius Test results that matched cultures results (same genus and species) were considered "positive agreement". We also evaluated at the number of participants who had negative cultures, but had a positive Karius Test.
Number of Participants With a Pathogen Identified by the Karius Test (at Time Point IP2) and Standard Culture Methods
时间窗: Inpatient Sample 2 (IP2) - Within 48 hours of the initial sample
We evaluated the total number of participants that had a pathogen identified by the Karius Test ("positive Karius Test") at time point IP2 (within 48 hours of the initial sample). We compared the results of the Karius Test to those with a positive culture (gold standard) for each participant. Karius Test results that matched cultures results (same genus and species) were considered "positive agreement". Karius Test results that identified an organism different from the organism identified in culture were considered "discordant results" Karius Tests results that did not identify any organism were consider "negative"
次要结局
- Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Timepoint IP3(Inpatient Sample 3 (IP3) - Within 48 hours of the second inpatient sample)
- Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point OP1(Outpatient Sample 1 (OP1) - 1-2 weeks after hospital discharge)
- Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point OP2(Outpatient Sample 2 (OP2) - 3-6 weeks after hospital discharge)
- Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point OP3(Outpatient Sample 3 (OP3) - 6-8 weeks after hospital discharge)
- Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point IP1(Inpatient Sample 1 (IP1) - Within 48 hours of admission)
- Microbial Cell Free DNA Level (cfDNA) in Molecules Per Microliter (MPM)(From hospital admission to hospital discharge, up to 3 months)
- Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point IP4(Inpatient Sample 4 (IP4) - Within 48 hours of the third inpatient sample)
- Microbial Cell Free DNA (cfDNA) in Molecules Per Microliter (MPM) at Time Point IP2(Inpatient Sample 2 (IP2) - Within 48 hours of the admission sample)
研究者
Jack Schneider
Assistant Professor of Clinical Medicine and Clinical Pediatrics
Indiana University