Contribution of Metagenomic Sequencing Using Nanopore Technology to the Management of Post-traumatic Bone and Joint Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Concordance between the microbiological documentation obtained by sequencing and that of the reference technique (culture)
研究概览
简要总结
The value of next-generation sequencing (NGS) using Nanopore technology has been demonstrated in the case of diabetic patients' wounds or in prosthetic joint infections. The aim of this study is to demonstrate its relevance as a new diagnostic approach for fracture-related infections (FRI).
Bone samples from patient with FRI will be submitted to shotgun metagenomic Next-generation sequencing using Oxford Nanopore Technology (ONT) in order to establish its diagnostic value in this context in comparison with the reference method.
详细描述
Tissue samples from patients with FRI used for routine culture and remaining after this step will be retrieved for metagenomic sequencing.
Both DNA extraction and host-DNA depletion steps will be performed. The nanopore ligation sequencing protocol along with native barcoding will be used to carry out DNA library preparation. Sequencing will be run using ONT GridION device. The generated reads will be computerized to be assigned at each taxonomic levels. The results will be compared to those of routine diagnosis to determine NGS concordance with culture.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosis of fracture-related infection (FRI consensus group)
- •Patient scheduled to undergo a bone and/or soft-tissue biopsy as part of routine care
排除标准
- •Patient opposition
- •Patient under a legal protection measure.
结局指标
主要结局
Concordance between the microbiological documentation obtained by sequencing and that of the reference technique (culture)
时间窗: 1 month
Metagenomic sequencing will be used to determine the microbiome of fracture-related infections. Data will be compared with those of reference microbiological identification techniques (culture).
次要结局
- Time to obtain final microbiological results by sequencing compared with the reference technique (culture)(1 month)
- Number of cases in which an adjustment of targeted antibiotic therapy would be made based on NGS results.(1 month)
- Microbial abundance defined by the number of reads (sequence reads) obtained per phylotype(1 month)