Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support - Accuracy and Effect on Antibiotic Consumption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- All-cause 30-day mortality
研究概览
简要总结
The study aims to assess the accuracy and impact of rapid diagnosis and rapid diagnosis decision support on different aspects of antibiotic consumption when implemented alone or together.
详细描述
This interventional study in two centers compares two groups with each other and with a pre-intervention control group. In group 1 rapid techniques for handling urine cultures will be the only intervention. In group 2 rapid diagnostics will be supplemented with real-time antimicrobial stewardship decision support (RADS). In each center two departments will be involved.
Urine samples present at the laboratory at opening on weekdays will be screened using urine flow cytometry and microscopy of centrifuged gram stained urine. Samples found positive for significant mono microbial bacteriuria will be investigated further by using direct automated phenotypic identification and antimicrobial susceptibility determination and screened for inclusion in the interventional study.
In one of the centers, rapid techniques will be coupled to real-time antimicrobial stewardship decision support (RADS). RADS will be given by telephone to a designated clinician with the aim of:
- Switch to active treatment if non-working empirical treatment
- De-escalate broad spectrum empiric treatment when feasible
- Promote early intravenous to per oral switch
- Shorten treatment duration
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Urine sample present at the laboratory weekdays
- •At least 11 ml of urine in sample
- •Admitted to surgical or medical ward.
- •Urine sample taken on admission to hospital.
- •Rapid diagnostics suggesting mono microbial growth of > 100.000 microbes/ml urine.
- •Clinical and laboratory signs/symptoms of urinary tract infection at time of sample delivery.
排除标准
- •Other simultaneous infections that warrant systemic antimicrobial therapy or surgery.
结局指标
主要结局
All-cause 30-day mortality
时间窗: 30 days
次要结局
- Adherence to guidelines for empirical therapy(Recorded at inclusion or within 30 days after admission/inclusion.)
- Total antibiotic consumption in intervention groups and control group compared(Recorded at inclusion or within 30 days after admission/inclusion.)
- Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group.(Recorded 30 days after admission/inclusion.)
- Time from admission to optimal antibiotic therapy(Recorded 30 days after admission/inclusion.)
- Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment(Recorded within 30 days after admission/inclusion.)
- Treatment duration - intravenous/per oral(Recorded within 30 days after admission/inclusion.)
- Intensive care unit length of stay(Recorded within 30 days after admission/inclusion.)
- Hospital length of stay(Recorded within 30 days after admission/inclusion.)
- Frequency of adherence to treatment suggestions given as RADS(Recorded within 30 days after admission/inclusion.)
- Frequency of readmission for urinary tract infection within 30 days of discharge(Recorded within 30 days after admission/inclusion.)
- Turnaround time of rapid diagnostic procedures compared to conventional diagnostics(Recorded within 30 days after admission/inclusion.)
- Accuracy of rapid diagnostic procedures compared to conventional diagnostics(Recorded within 30 days after admission/inclusion.)