PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Average antibiotics duration
研究概览
简要总结
The purpose of this study is to give conclusive evidence on whether serial PCT (Procalcitonin) measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU (Intensive Care Unit).
详细描述
In this study, the investigators aimed to design a multi-center trial addressing aforementioned flaws. The investigators will set stricter inclusion criteria, collect complete data on relapse or secondary infection, and include sufficient number of patients to show non-inferiority to conventional therapy by a delta margin of 10% [11]. The investigators aimed to give conclusive evidence on whether serial PCT measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU.
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
- 1 Month 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with laboratory- or image-confirmed severe infection at admission or during stay in pediatric ICU will be eligible for inclusion.
- •* Definition of laboratory- or image-confirmed severe infection:
- •Two or more of four signs of inflammation:
- •Temperature >38.3℃ or <36℃
- •Heart rate > 90 beats/min
- •Respiratory rate >20 breaths/min or PaCO2 (Arterial pressure of carbon dioxide) < 32 mmHg
- •WBC (White Blood Cell count) > 12,000 cells/mm3, <4000 cells/mm3, or >5% band-form WBC
- •Initial Procalcitonin > 0.5 ng/mL
- •Presence of either laboratory or image evidence of infection
- •Laboratory evidence: Sign of inflammation in urine, CSF (Cerebrospinal Fluid), ascites, pleural effusion or local abscess
- •Image evidence: Compatible findings on Chest X ray, ultrasound, CT (Computed Tomography), MR image (Magnetic Resonance Image)
排除标准
- •Age greater than 15 years or less than 1 month
- •Known pregnancy
- •Expected ICU stay less than 3 days
- •Neutropenia: ANC (Absolute Neutrophil Count) <500/mm3
- •Specific infections for which long-term antibiotic treatment is strongly recommended:
- •Lobar pneumonia or empyema
- •Bacterial meningitis
- •Osteomyelitis
- •Infective endocarditis
- •Local abscess
- •Mediastinitin
研究组 & 干预措施
Procalcitonin-guided treatment
The duration of antibiotics will be determined by the procalcitonin levels.
干预措施: Procalcitonin-guided treatment (Behavioral)
Conventional treatment
The duration of antibiotics will be determined by the treating physician.
干预措施: Conventional treatment (Behavioral)
结局指标
主要结局
Average antibiotics duration
时间窗: 28 days
Efficacy endpoint
28-day mortality rate
时间窗: 28 days
Safety endpoint
次要结局
- Proportion of antibiotics use in both arms(28 days)
- Length of ICU stay(90 days)
- Recurrence of fever within 72 hours of antibiotics discontinuation(28 days)
- SOFA score (Sequential Organ Failure Assessment score)(28 days)
- Reinfection rate between 72-hours and 28 days post antibiotics discontinuation(28 days)
- 90-day all-cause mortality(90 days)
- 90-day readmission rate(90 days)