Bloodstream Infection Due to Multidrug-Resistant Organisms - Multicenter Study on Determinants of Clinical Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 6,000
- 试验地点
- 6
- 主要终点
- Long-term mortality due to bloodstream infection
研究概览
简要总结
Continual surveillance of both community-acquired and nosocomial bloodstream infections for specific target organisms. Analysis of comorbidities, complications, bacterial resistance patterns, bacterial genomics (e. g. via WGS and MLST typing) for the determinants of clinical outcomes. The clinical outcomes are investigated both in the short-term (up until discharge) and the long-term (six months after index blood culture by standardized questionnaire). A predictive point-of-care score is to be developed based on these data to define high-risk patient populations requiring more intensive diagnostic and/or treatment regimens.
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
- •At least 18 years old
- •Informed consent given either by patient or guardian
- •Inpatient
- •At least one blood culture positive for one of the following bacteria: Staphylococcus aureus, Enterococcus spp., Escherichia coli, Enterobacter spp., Klebsiella spp., Acinetobacter baumannii, Pseudomonas aeruginosa
排除标准
- •Less than 18 years old
- •Not capable of giving informed consent nor informed consent given by guardian
- •Outpatient
- •No blood cultures positive for any of the target organisms
结局指标
主要结局
Long-term mortality due to bloodstream infection
时间窗: Up to 6 months
Mortality due to bloodstream infection up to long-term follow-up after 6 months in association to causative species, resistance pattern, comorbidities, complications etc.
Short-term mortality due to bloodstream infection
时间窗: From index blood culture to discharge, an average of 16 days
Mortality due to bloodstream infection up to hospital discharge in association to causative species, resistance pattern, comorbidities, complications etc.
Long-term morbidity due to bloodstream infection
时间窗: At 6 months
Morbidity as measured by the SF-36 questionnaire due to bloodstream infection after 6 months in association to causative species, resistance pattern, comorbidities, complications etc.
次要结局
未报告次要终点
研究者
Prof. Dr. Evelina Tacconelli
Prof. Infectious Diseases, FESCMID,ESCMID Education Officer,EUCIC Chair
University Hospital Tuebingen