NCT02413242已完成不适用
Advanced Understanding of Staphylococcus Aureus and Pseudomonas Aeruginosa Infections in EuRopE - ICU
Jan Kluytmans1 个研究点 分布在 1 个国家目标入组 2,031 人开始时间: 2015年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,031
- 试验地点
- 1
- 主要终点
- Incidence of P. aeruginosa ICU pneumonia
研究概览
简要总结
Intensive Care Unit (ICU) acquired pneumonia, including ventilator-associated pneumonia, is a frequently occurring health-care associated infection, which causes considerable morbidity, mortality and health care costs. Important pathogens causing ICU pneumonia are Staphylococcus aureus and Pseudomonas aeruginosa. The epidemiology of ICU pneumonia and patient-related and contextual factors is not fully described, but is urgently needed to support the development of effective interventions.
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
- •Participant is 18 years or older at the time of enrollment.
- •Participant is on mechanical ventilation at ICU admission, or is (expected to be) within 24 hours thereafter, based on investigator's judgment.
- •Expected stay in ICU is 48 hours or longer based on investigator's judgment.
- •SA colonization status is known within 72 hours after start of first episode of mechanical ventilation and according to the result, the patient qualifies for enrollment.
- •Written informed consent from subject / legally accepted representative within 72 hours after start of first episode of mechanical ventilation.
排除标准
- •Previous participation as a subject in the study cohort of this study.
- •Simultaneous participation of the subject in any preventive experimental study into anti-staphylococcus or anti-pseudomonas aeruginosa interventions.
- •Expected death (moribund status) within 48h, or ICU discharge of the participant within 24h, at the moment of informed consent.
结局指标
主要结局
Incidence of P. aeruginosa ICU pneumonia
时间窗: date of ICF until ICU discharge (on average 7 days after ICF)
Incidence of S. aureus ICU pneumonia
时间窗: date of ICF until ICU discharge (on average 7 days after ICF)
次要结局
- Incidence of P. aeruginosa ICU pneumonia stratified by MDR-PA vs. S-PA(date of ICF until ICU discharge (on average 7 days after ICF))
- Time to all cause ICU pneumonia(day of ICU admission until ICU discharge (on average 7 days after ICU admission))
- Incidence of ICU bacteremia per etiologic agent (in case of S. aureus and/or P. aeruginosa and for all clinically relevant other pathogens)(date of ICF until ICU discharge (on average 7 days after ICF))
- Incidence of all cause ICU pneumonia(date of ICF until ICU discharge (on average 7 days after ICF))
- Time to P. aeruginosa ICU pneumonia(day of ICU admission until ICU discharge (on average 7 days after ICU admission))
- Prevalence of S. aureus / P. aeruginosa colonization(at ICU admission)
- Incidence of S. aureus ICU pneumonia stratified by MRSA vs. MSSA(date of ICF until ICU discharge (on average 7 days after ICF))
- All-cause mortality(At day 90 after ICU admission)
- Time to S. aureus ICU pneumonia(day of ICU admission until ICU discharge (on average 7 days after ICU admission))
- Time to all cause ICU bacteremia(day of ICU admission until ICU discharge (on average 7 days after ICU admission))
- Time to death of any cause(day of ICU admission until day 90 or ICU discharge, whichever comes first)
研究者
Jan Kluytmans
Professor
UMC Utrecht
研究点 (1)
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