Impact of Rapid Pathogen Identification From Blood Cultures (RABbIT - Rapid Blood Culture Intervention Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 832
- 试验地点
- 1
- 主要终点
- Time from positive blood culture result to effective/optimal antibiotics
研究概览
简要总结
Septic shock carries high mortality, which may be exacerbated by inappropriate initial therapy. Inappropriate therapy may result from unanticipated antimicrobial resistance. Conversely, positive blood cultures may result from contamination, leading to unnecessary therapy and procedures and possibly prolonged hospitalization. Clinicians may also resort to broad spectrum antimicrobials and be hesitant to de-escalate while awaiting susceptibility results.
The investigators hypothesize that rapid identification of pathogens and antimicrobial resistance will ameliorate the above problems and improve time to optimal therapy, avoid unnecessary therapy and ultimately improve patient outcomes. While there are a number of in-vitro and uncontrolled clinical studies, there is a paucity of well-designed clinical trials objectively examining the real-world clinical and health-economic impact of such technology. To date only one randomised trial has been performed in the US (ClinicalTrials.gov NCT01898208), at a setting with low endemic rates of antimicrobial resistance. This is a companion study to NCT01898208. The investigators aim to study the clinical impact and cost-effectiveness of a strategy for rapid pathogen and resistance detection in a setting with a moderate to high levels of antimicrobial resistance.
详细描述
Hypothesis
- Rapid pathogen identification from blood cultures, including early identification of resistance (via specific genetic markers or phenotypic tests), will allow timelier initiation of appropriate antibiotic therapy and improved patient outcomes
- Rapid organism identification from blood cultures will allow timelier initiation of effective and optimal antibiotic therapy; minimizing the use of unnecessary antibiotics, including combination therapy
Devices to be studied for this proposed study:
- BCID panel (Biofire Diagnostics Inc., bioMerieux) : The BCID panel is an FDA-approved nucleic acid amplification test (based on nested polymerase chain reaction) which detects Gram positive, Gram negative, the major Candida species and antimicrobial resistance markers (mecA for methicillin resistance, van A/B for vancomycin resistance, blaKPC for Klebsiella pneumoniae carbapenemase (KPC)) directly from positive blood cultures in < 1 - 1.5 hours
- Rosco Diagnostica extended-spectrum beta-lactamase (ESBL) and carbapenemase screen kit (Rosco Diagnostica): These kits are CE-marked (Approved in the European Union) rapid chromogenic tests for ESBL/ carbapenemase detection from both blood cultures and cultured bacterial colonies.
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
- 21 Years 至 103 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21 years and above to 103 years
- •Blood culture flagged positive on automated instrument, with Gram positive, Gram negative bacteria or Yeast on Gram staining (including polymicrobial blood cultures)
- •Ability to provide informed consent or ability to obtain informed consent from legal guardian/representative (verbal and written)
排除标准
- •Patients whose blood cultures turn positive, but have no organism seen on Gram stain.
- •Patients who have been previously enrolled.
- •Patients who withdraw their consent (verbal or written).
- •Patients with any positive blood culture in the preceding 7 days.
研究组 & 干预措施
Rapid diagnostic arm
Standard Tan Tock Seng Hospital (TTSH) practices (bacterial culture and susceptibility testing) AND FilmArray Blood Culture ID (BCID) Panel test AND Rosco Diagnostica ESBL and carbapenemase screen will be performed.
The Interventions to be administered are the rapid diagnostic tests: FilmArray Blood Culture ID (BCID) Panel test AND Rosco Diagnostica ESBL and carbapenemase screen.
Subjects will be recruited 8am-3pm daily, weekdays only. Results of the BCID and Rosco test will be communicated to the managing physicians by phone in real-time.
干预措施: Filmarray Blood Culture ID (BCID) panel (Device)
Rapid diagnostic arm
Standard Tan Tock Seng Hospital (TTSH) practices (bacterial culture and susceptibility testing) AND FilmArray Blood Culture ID (BCID) Panel test AND Rosco Diagnostica ESBL and carbapenemase screen will be performed.
The Interventions to be administered are the rapid diagnostic tests: FilmArray Blood Culture ID (BCID) Panel test AND Rosco Diagnostica ESBL and carbapenemase screen.
Subjects will be recruited 8am-3pm daily, weekdays only. Results of the BCID and Rosco test will be communicated to the managing physicians by phone in real-time.
干预措施: Rosco Diagnostica ESBL/carbapenemase screen kit (Device)
Standard of care (control)
Standard Tan Tock Seng Hospital (TTSH) practices (bacterial culture and susceptibility testing) will be used. FilmArray BCID and Rosco Diagnostica ESBL and carbapenemase screen will NOT be performed. Subjects will be recruited 8am-3pm daily, weekdays only.
结局指标
主要结局
Time from positive blood culture result to effective/optimal antibiotics
时间窗: Approximately 14 days after positive blood culture
An effective antibiotic is defined as an antibiotic regimen to which the bacterial/fungal isolate is susceptible (or predicted to be susceptible for Candida, per speciation).An optimal antibiotic is defined as an antibiotic regimen to which the bacterial/fungal isolate is susceptible/predicted to be susceptible, which is the most narrow spectrum and targeted, as recommended by institutional guidelines. This will be considered as the time from the positive Gram stain to first effective and the first optimal antibiotic.
次要结局
- Clinical outcome (All-cause related mortality)(1 year)
- Clinical outcome (Quality of life)(1 year)
- Cost-effectiveness analysis(Up to 1 year after enrolment and using a 'modeled horizon' based on sepsis-adjusted life expectancies)
- Duration of bacteremia/fungemia (days)(Patient-dependent variable, estimated up to 7 days)
- Mean Total Hospitalization Costs Per Subject(Approximately 7 days after positive blood culture for up to an estimated 24 weeks)
- Mean Laboratory Costs Per Subject(Approximately 7 days after positive blood culture for up to an estimated 24 week)
- Clinical outcome (Infection related mortality)(1 year)
- Time to isolation precautions(Estimated up to 5 days)
- Time from positive blood culture result to bacterial identification(Approximately 3 days)
- Duration of hospitalization (days)(Participants were followed for the duration of hospital stay, approximately 28 days)
- Antibiotic-associated adverse events(Approximately 14 days after positive blood culture)
- Antimicrobial utilization (hours/days of therapy)(Approximately 4 days after enrollment)
- Mean Antimicrobials Costs Per Subject(Approximately 7 days after positive blood culture and for duration of entire hospitalization)
- Time on effective/optimal antibiotics within first 96 hours of positive blood culture(First 96 hours after blood culture turns positive)
研究者
Shawn Vasoo
Consultant
Tan Tock Seng Hospital