Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Antibiotic Treatment for More Than 72 Hours
研究概览
简要总结
Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success.
Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf antibiotic therapy in suspected neonatal early-onset sepsis.
详细描述
This single-centre, prospective randomized intervention study was conducted in a tertiary neonatal and paediatric intensive care unit in the Children's Hospital of Lucerne, Switzerland between June 1, 2005 and December 31, 2006. All term and near term infants with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional laboratory parameters (standard group) or to Procalcitonin-guided treatment (Procalcitonin-group). Minimum duration of antibiotic therapy was (48)-72 hours in the standard group, whereas in the Procalcitonin group antibiotic therapy was discontinued when two consecutive Procalcitonin values were below predefined age-adjusted cut-off values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term and near-term infants with a gestational age of more than 34 weeks
- •Admitted to the Children's Hospital of Lucerne, Switzerland
- •Suspected neonatal early-onset sepsis
- •Antibiotic therapy
- •Parental consent
排除标准
- •Surgery in the first 3 days of life
- •Severe congenital malformations
- •Chromosomal abnormalities
结局指标
主要结局
Antibiotic Treatment for More Than 72 Hours
时间窗: 1 month
Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)
Absolute Duration of Antibiotic Therapy
时间窗: 1 month
Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)
次要结局
未报告次要终点