Impact of Multiplex Respiratory Pathogen Testing on Antimicrobial Consumption and Hospital Admissions at Pediatric Emergency Room: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,350
- 试验地点
- 2
- 主要终点
- Proportion of children with antibiotic prescription at emergency room
研究概览
简要总结
The main objective of the trial is to evaluate the effect of point-of-care testing of respiratory pathogens at a pediatric emergency room on the antibiotic consumption and hospital admissions in acutely ill children.
详细描述
The study is a randomized controlled trial including children 0 up to 17 years of age with fever or acute respiratory infection at a pediatric emergency department in university hospital. In total 1668 subjects will be randomly allocated to undergo point-of-care multiplex respiratory pathogen testing with results ready within approximately one hour or to a control group with testing according to clinical judgement and results ready within next office day. Subjects will be randomized on admission and unequal allocation ratio of 2:1 (1112 subjects to intervention and 556 subjects to control arm) will be used. Data on rate of hospitalization, antibiotic prescriptions, ancillary testing and length of visit will be collected using medical record system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any respiratory symptom defined as tachypnea, shortness of breath, apnea, wheezing, cough, rhinitis, croup, sneezing, ear ache, or sore throat AND/OR
- •Fever > 38.0 C
排除标准
- •Need of resuscitation at emergency room
- •Need of immediate transfer to pediatric intensive care unit
结局指标
主要结局
Proportion of children with antibiotic prescription at emergency room
时间窗: Up to 1 day after study entry
Antibiotic consumption at emergency room
次要结局
- Proportion of children receiving correct pathogen directed therapy(0-7 days after study entry)
- Proportion of children with antibiotics in one week(0-7 days after study entry)
- Proportion of children receiving macrolide antibiotic at pediatric emergency room(Up to 1 day after study entry)
- Proportion of infants aged < 3 months receiving macrolide antibiotic at pediatric emergency room(Up to 1 day after study entry)
- Proportion of children admitted to hospital(0-7 days after study entry)
- Proportion of children with readmission to hospital or revisit at emergency room(0-7 days after study entry)
- Proportion of children with outpatient telephone contact within 7 days after discharge from emergency room(0-7 days)
- Number of diagnostic tests per child other than point-of-care test performed within one week(0-7 days after discharge)
- Number of other diagnostic tests than point-of-care test performed at emergency room(Up to 1 day after study entry)
- Proportion of children with admission to pediatric intensive care unit or intensive care unit(0-30 days)
- Proportion of children who died within one month after study entry(0-30 days)
- Cost in euros per child per visits(0-7 days after study entry)
- Length of stay at emergency room in minutes(Up to 1 day after study entry)
- Time to initiation of correct pathogen directed therapy(0-7 days after study entry)