Effect of Procalcitonin-guided Decision Making on Duration of Antibiotic Therapy in Suspected Neonatal Early-onset Sepsis: Multicenter Prospective Randomized Intervention Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- The absolute reduction of the duration of antibiotic therapy with unchanged outcome
研究概览
简要总结
In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific and currently available tests have poor positive and negative predictive values. The investigators hypothesize that procalcitonin (PCT) has a reliable negative predictive values to allow a reduction in duration of empiric antibiotic therapy in suspected neonatal early-onset sepsis with unchanged outcome. This study is designed as a multi-center, prospective, randomized intervention trial. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the probability of infection during hospitalisation. In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PCT values are within the normal range.
详细描述
Detailed description according our pilot study (see reference). This trial is designed to exclude a difference in rate of re-infection or death greater than 2%. Assuming a 2% reinfection/death rate in each group, 770 patients are required for a power of 80% at alpha=0.05. To allow for some unevaluable cases 800 per group will be included. Based on the data of the pilot study (see reference), with a number of 770 per group a difference between mean antibiotic therapy durations of 10 hours can be detected at two-sided alpha of 0.05 with a power of 95%.
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 > 34 weeks
- •Suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy
- •Parental consent
排除标准
- •Surgery in the first week of life
- •Severe congenital malformations
结局指标
主要结局
The absolute reduction of the duration of antibiotic therapy with unchanged outcome
时间窗: 1 month
Unchanged outcome = proportion of infants with a recurrence of infection requiering additional courses of antibiotic therapy within 72 hours after ending antibiotic therapy and/or death in the first month of life
次要结局
- Duration of hospitalisation(1 month)
研究者
Stocker Martin
MD
Luzerner Kantonsspital