NCT05247281Enrolling By Invitation不适用
Randomized Controlled Trial Investigating the Use of Next-generation Sequencing in Directing the Antimicrobial Treatment of Periprosthetic Joint Infection
Center for Innovation and Research Organization17 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年9月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 250
- 试验地点
- 17
- 主要终点
- Number of participants who have been diagnosed with prosthetic joint infection as assessed by the 2018 International Consensus Definition of prosthetic joint infection
研究概览
简要总结
This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adults (age > 18 years)
- •Undergoing single stage revision or 1st stage resection arthroplasty/spacer placement for PJI (ICM-positive) of the hip or knee
- •Written informed consent
排除标准
- •Ongoing participation in another clinical trial
- •Megaprosthesis
结局指标
主要结局
Number of participants who have been diagnosed with prosthetic joint infection as assessed by the 2018 International Consensus Definition of prosthetic joint infection
时间窗: 90 days from time of surgery
Diagnosis of re-infection following surgery and treatment for prosthetic joint infection
次要结局
- Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records(one year from time to surgery)
研究者
研究点 (17)
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