Duration of Bloodstream Infection as Measured by Conventional Cultures Compared With Novel Culture Independent Systems and Persistence of Biomarkers Associated With Severe Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 6
- 主要终点
- Duration of bloodstream infection measured by conventional blood cultures and the T2 magnetic resonance assay
研究概览
简要总结
Infection with bacteria and other germs in the blood can be deadly. How long germs stay in the blood is important for two reasons. The first is that if they stay in the blood for many days it is a sign that antibiotics may need to be changed. The second is that if they stay in the blood for only a short time it may give doctors confidence to switch to tablets and consider early discharge from hospital. This study is evaluating the diagnostic and prognostic performance of two novel technologies when used to measure the duration of the bloodstream infection.
详细描述
Bloodstream infection is highly significant and is associated with mortality rates of between 10 and 25%.
For some infection types (for example, Staphylococcus aureus) a longer duration of bacteria being present in the blood is linked to higher mortality. With traditional microbiologic techniques, bloodstream infection with gram-negative bacteria is usually quite brief. However, new culture independent bacteraemia detection systems (such as T2 magnetic resonance assay) are more sensitive than traditional blood culture systems and may show that gram-negative bacteraemia is more prolonged in some patients than has previously been thought. This observational study will investigate the correlation between the duration of bloodstream infection by mean of traditional blood culture techniques with:
- Duration of the bloodstream infection by mean of the T2 magnetic resonance assay, a new culture independent bacteraemia detection system.
- Persistence of inflammation as measured by the SeptiCyte RAPID test, a host response assay able to differentiate infectious from sterile inflammation.
The study will also correlate each measure of the duration of bacteraemia with microbiological and clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Patients who have proven bloodstream infection with any T2-on panel pathogen (Enterococcus faecium, S. aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli and Candida spp.)
排除标准
- •Palliative care approach
- •Failure to give written informed consent (by patient or their legal representative)
- •Polymicrobial index blood culture
结局指标
主要结局
Duration of bloodstream infection measured by conventional blood cultures and the T2 magnetic resonance assay
时间窗: Days 1-4
The T2 system is a new diagnostic detection method utilizing miniaturized magnetic resonance technology. The T2 system has been shown to quickly and accurately identify molecular targets within patient samples without the need for purification or extraction of target molecules from the sample. It does not require bacterial culture and can detect organisms as low as 1 CFU/mL in whole blood. The study will compare the duration of detectable pathogens in the bloodstream as measured by the T2 with the duration of bloodstream infection according to conventional cultures
Persistent infection defined as metastatic infection and lack of source control
时间窗: Days 1-4
The study will explore the correlation between the duration of detectable pathogens in the bloodstream as measured by the T2 (duration of T2emia) and the presence of persistent infection
次要结局
- Persistent infection(Day 1-4)
- Short-term clinical outcome (SOFA success)(Days 1-7)
- Long-term clinical outcome(6-months from the index BSI)
研究者
Professor David L. Paterson
Professor
The University of Queensland