Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia or Fungemia From Positive Blood Culture Bottles, Combining Fast Identification of Bacteria and Fungi and Evaluation of Bacterial Resistance to First Line Antibiotics.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Delay from suspicion of sepsis to optimized antibiotic/antifungal treatment
研究概览
简要总结
This study evaluates the clinical benefit of a rapid test for fast diagnosis of bacteremia and fungemia from positive blood cultures in case of sepsis. This assay enables rapid identification of bacteria and fungi and allows to evaluate bacterial resistance to first line antibiotics. The clinical and medico-economic impact of this assay used in addition to the current diagnosis strategy (half of the patients) will be compared to the current diagnostic strategy alone (other half of the patient).
详细描述
Bacteremia and fungemia are severe complications, sometimes life-threatening, of every sepsis. During septicemia, every hour matters to start an appropriate antibiotic or antifungal treatment as every hour of delay is associated to higher death rate.
The rapid multiplex PCR assay that is evaluated in this study allows to identify in 60 to 90 minutes, the bacteria or fungi that is present in the positive blood culture bottles and to identify resistance markers to first line antibiotics that are used to treat sepsis. This strategy allows quicker adaptation of antibacterial or antifungal treatment based on the species of the bacteria or fungi identified and on the results of the resistance markers compared to current diagnosis strategy of bacteremia or fungemia. This quicker adaptation could lead to improved survival rate, reduced complications of sepsis, reduced hospital stay length and could reduce the use of large spectrum antibiotics.
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
- Single (Participant)
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
- •Patient with bacteremia and/or fungemia defined by :
- •1/ the presence of clinical signs of sepsis; AND 2/ a positive blood culture, i.e. the growth of at least one species of bacteria or micromyces in at least one blood culture vial
- •Patient Hospitalized at Grenoble University Hospital (only North site) and seen by a physician from the antibiotic stewardship team
- •First blood culture positive for the patient's sepsis episode
- •Informed and written consent signed by the patient or his legal representative or the doctor in case of emergency.
排除标准
- •Patients mentioned in the law articles L1121-5 to L1121-8 from French Health Code
- •Patients hospitalized in palliative care unit
- •Persons with an estimated survival of less than one month
结局指标
主要结局
Delay from suspicion of sepsis to optimized antibiotic/antifungal treatment
时间窗: Follow up is set to hospital length stay with a maximum of 30 days
Delay between first sampling of blood cultures for sepsis and optimized antibiotic/antifungal treatment. Treatment will be considered optimized if it is active on the bacteria/fungi responsible for sepsis and if it follows current treatment recommendations for the bacteria/fungi identified.
次要结局
- Medical evaluation of the consequences of the innovative strategy compared to current strategy : 30-day mortality(Hospital length stay with a maximum of 30 days)
- Medical evaluation of the consequences of the innovative strategy compared to current strategy : antibiotic treatment duration(Hospital length stay with a maximum of 30 days)
- Medical evaluation of the consequences of the innovative strategy compared to current strategy : complication rate(Hospital length stay with a maximum of 30 days)
- Economic evaluation of the costs of the innovative compared to current strategy(Hospital length stay with a maximum of 30 days)
- Economic evaluation of the hospitalization costs of the innovative strategy compared to current strategy(Hospital length stay with a maximum of 30 days)
- Economic evaluation of the medical imaging costs of the innovative strategy compared to current strategy(Hospital length stay with a maximum of 30 days)
- Medical evaluation of the consequences of the innovative strategy compared to current strategy : length of hospital stay(Hospital length stay with a maximum of 30 days)
- Medical evaluation of the consequences of the innovative strategy compared to current strategy : delay of antibiotic/antifungal treatment modification at several time points(Hospital length stay with a maximum of 30 days)
- Medical evaluation of the consequences of the innovative strategy compared to current strategy : rate of antibiotic/antifungal treatment modification at several time points(Hospital length stay with a maximum of 30 days)
- Economic evaluation of the treatments costs of the innovative strategy compared to current strategy(Hospital length stay with a maximum of 30 days)
- Economic impact of the introduction of the innovative strategy for Grenoble University Hospital(Extrapolation of the costs for a one year period)