Procalcitonin-Guided Antimicrobial Discontinuation Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Sepsis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
研究概览
简要总结
The current study aims to validate the diagnostic use of PCT assessing its capability to individualize and shorten the duration of antibiotic therapy in critically ill patients with suspected or confirmed sepsis.
In particular, no well-designed intervention study has properly examined the following hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic treatment duration in critically ill patients with suspected or documented sepsis, without harming patient safety.
详细描述
Primary objective:
To assess the effect of repeated PCT measurements in critically ill patients with clinically suspected or microbiologically documented sepsis on duration of antimicrobial use and to compare this strategy to standard clinical practice, by using an improved PCT assay with a sensitivity of 0.06 ng/ml.
Secondary objectives:
To determine the impact of repeated PCT measurements on patient outcome (morbidity, mortality, emergence of antibiotic resistance and nosocomial super-infections).
Main measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single
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 with clinically suspected or microbiologically confirmed bacterial sepsis
- •Informed consent
排除标准
- •Patients with microbiologically documented infections caused by the following microorganisms: Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis, Staphylococcus aureus
- •Patients with fungal infections
- •Patients with severe infections due to viruses or parasites (e.g. hemorrhagic fever, malaria)
- •Patients with suspected or confirmed bacterial meningitis or endocarditis
- •Patients with localized, deep-seated abscesses (e.g. brain abscess) without systemic sepsis
- •Patients with chronic, localized infections (e.g. chronic osteomyelitis) without systemic sepsis
- •Neutropenic and other severely immuno-compromised patients (patients infected with human immunodeficiency virus and a CD4 count < 200; patients on immuno-suppressive therapy after solid organ transplantation; patients with cystic fibrosis)
- •Withholding of life-support
- •Early discharge or death (< 24 hours after admission)
- •Complete absence of antimicrobial treatment despite suspicion of sepsis
结局指标
主要结局
Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
次要结局
- Cure and failure rate of infection (in N recurrent infections per 100 patients)
- 28-day case-fatality rate (in N deaths per 100 patients)
- Length of hospital stay (in days)
- Costs of antimicrobial therapy (in CHF)
- Rate of nosocomial super-infection (in N super-infections per 100 patients)
- Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-days)