Direct Detection of ESKAPE Pathogens From Whole Blood Using T2MR Bacteria Panel in Patients With Pyogenic Spondylodiscitis and Infective Endocarditis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of the T2 Bacteria Panel
研究概览
简要总结
Our prospective observational study focuses on the rapid detection of etiologic agents of pyogenic spondylodiscitis and infective endocarditis using the T2 Bacteria Panel (T2Biosystems). This diagnostic method combines polymerase chain reaction (PCR) and T2 magnetic resonance for detection of bacterial DNA from whole blood samples. It detects six pathogens known by the acronym ESKAPE (E. coli, S. aureus, K. pneumoniae, A. baumannii, P. aeruginosa, and E. faecium). In recent years, similar studies using the Bacteria Panel and Candida Panel have been performed in patients with bloodstream infections, leaving us with optimistic results.The aim of this study is to verify whether T2B can identify the etiologic agents of localized infections, specifically spondylodiscitis and endocarditis, with better sensitivity and specificity and shorter time to result compared to conventional diagnostics from blood culture. Rapid detection of pathogen may reduce time to targeted pathogen-specific antibiotic therapy and subsequently improve outcomes, shorten the treatment and contribute to slowing the development of antibiotic resistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Diagnosis of spondylodiscitis or/and facet joint infection or/and sacroileitis
- •Diagnosis of infective endocarditis
- •Antibiotic treatment not received or not longer than 24 hours
- •Ability to give informed consent
排除标准
- •Spine infection or/and endocarditis not confirmed
- •Antibiotic treatment longer than 24 hours
- •Inability to give informed consent
结局指标
主要结局
Sensitivity and Specificity of the T2 Bacteria Panel
时间窗: 3 years
Sensitivity and specificity of the T2 Bacteria Panel for ESKAPE pathogens direct detection in patients investigated for suspected pyogenic vertebral infection and/or infective endocarditis, compared with conventional blood culture and/or other relevant biological samples culture .
Expected treatment outcomes in patients diagnosed by T2 Bacteria Panel
时间窗: 4 years
T2 Bacteria Panel is expected to shorten the time to result compared to conventional methods. Rapid detection of the bacteria followed by early pathogen-specific antibiotic therapy should improve the outcomes of patients with spondylodiscitis and infective endocarditis, e.g. mortality, morbidity and length of treatment.
次要结局
- Diagnostic utility of T2 Bacteria Panel in other localized infections(4 years)