Evaluating the Diagnostic Performance and Impact on Clinical Outcomes of the NuRapid-CRISPR Pathogen Profile Assay in ICU Patients With Sepsis
2026年5月6日 更新者：Sheng Wang MD PhD、Shanghai 10th People's Hospital
A Multicenter Prospective Study Evaluating the Diagnostic Performance and Impact on Clinical Outcomes of the NuRapid-CRISPR Pathogen Profile Assay in ICU Patients With Sepsis
This study is a prospective, multicenter, integrated trial designed to evaluate, from the perspectives of diagnostic performance and clinical utility, whether a diagnostic and treatment strategy based on the NuRapid-CRISPR rapid pathogen detection technology can reduce the 28-day all-cause mortality rate in patients with sepsis or septic shock in the ICU, compared to traditional pathogen culture.
The study consists of two parts:
- Diagnostic Accuracy Study: For all enrolled sepsis patients, microbiological specimens will undergo concurrent blinded testing, with NuRapid-CRISPR serving as the test of interest and traditional pathogen culture as the reference standard. A prospective comparison will evaluate differences between the two methods in key metrics such as pathogen detection rate, sensitivity, specificity, and turnaround time.
- Clinical Utility Cohort Study: All patients will undergo NuRapid-CRISPR testing as part of routine clinical care. Based on whether the rapid results are adopted clinically to guide early antimicrobial therapy decisions, the cohort will naturally form an exposure group (early treatment adjustments based on NuRapid-CRISPR results) and a control group (treatment primarily based on traditional culture results or empirical therapy). The study will prospectively compare the two groups in terms of the time to optimize antimicrobial therapy, coverage of the initial treatment spectrum, and infection-related clinical outcomes.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
396
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Du Yingying, Doctor
- 电话号码：+862166111524
- 邮箱：dyy9522@163.com
学习地点
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-
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Shanghai、中国
- Shanghai Dongfang Hospital
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接触：
- Zhu Feng
- 电话号码：+86 18801780080
- 邮箱：alexzhufeng@tongji.edu.cn
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Shanghai、中国
- Center for Critical Care Medicine, Tongji Hospital, Shanghai
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接触：
- Du Yingying, Doctor
- 电话号码：+862166111524
- 邮箱：dyy9522@163.com
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Shanghai、中国
- Yangpu District Central Hospital, Shanghai
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接触：
- Shi Bin
- 电话号码：+86 18918288036
- 邮箱：Joysb1969@sina.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age ≥ 18 years, length of stay in the ICU ≤ 24 hours;
- Meets the Sepsis-3.0 diagnostic criteria (an increase in SOFA score of ≥2 points from baseline, and evidence of infection);
- Clinically suspected sepsis or septic shock; the pathogen is unknown; the clinical plan is to collect sterile or suitable specimens, such as blood, respiratory specimens, cerebrospinal fluid, and ascites, for microbiological testing;
- Expected ICU stay of ≥48 hours and ability to complete at least 28 days of clinical follow-up;
- A written informed consent form signed by the patient or their legally authorized representative;
Exclusion Criteria:
- At the time of admission, the patient had already received a definitive pathogen diagnosis (based on microbiological culture, reliable molecular testing, or serological evidence), and targeted antimicrobial therapy against that pathogen had been initiated for more than 48 hours;
- Vital signs are extremely unstable; death is expected within 24 hours;
- Patients with severe primary immunodeficiency (e.g., AIDS, active hematologic malignancies, post-transplantation of solid organs or hematopoietic stem cells, or long-term use of high-dose glucocorticoids [prednisone ≥ 20 mg/day or equivalent dose for more than 4 weeks] or other potent immunosuppressants);
- Women who are pregnant or breastfeeding;
- The patient or their authorized representative has expressly refused to undergo any pathogen testing;
- It is not possible to obtain a suitable specimen for testing due to anatomical, physiological, or technical reasons;
- The patient is currently participating in another interventional clinical trial that may interfere with the assessment of the primary outcome of this study;
- The patient or their authorized representative has declined to participate in this study;
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：NuRapid-CRISPR
Eligible specimens from enrolled patients undergo NuRapid-CRISPR testing concurrently with submission for conventional culture.
Test results (including pathogen species and resistance gene information) are delivered to the attending physician via the hospital information system and/or telephone notification within 2-4 hours of validation.
The test report is accompanied by an abstract of the *Expert Consensus on Clinical Interpretation of Rapid Molecular Test Results and Treatment Recommendations*, developed by experts in infectious diseases and clinical microbiology.
Clinicians are encouraged and authorized to adjust antimicrobial treatment regimens as appropriate based on these rapid results and the patient's specific clinical condition, even before receiving conventional antimicrobial susceptibility test results.
The timing of decisions to adjust antimicrobial therapy based on rapid results, the specific regimens, and the rationale for such adjustments must be documented in detail.
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Adjusting early-stage treatment based on NuRapid-CRISPR results.
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有源比较器：Pathogen culture
Patient specimens were submitted for conventional pathogen culture and antimicrobial susceptibility testing in accordance with standard clinical procedures.
The NuRapid-CRISPR assay was performed concurrently; however, its results were blinded to clinicians until the conventional culture report was issued and were not used as a basis for clinical decision-making.
The initial selection and adjustment of antimicrobial agents were based entirely on clinical experience, routine inflammatory markers such as procalcitonin, and subsequent conventional culture and susceptibility test results.
All treatment decisions and their rationale were routinely documented.
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Primarily based on traditional cultivation methods or empirical treatment.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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28-day all-cause mortality rate
大体时间：From the date of randomization through Day 28 (±2 days)
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Death from any cause occurring between the date of randomization and day 28 (±2 days).In-hospital deaths: Recorded in real time through daily medical record reviews.
Out-of-hospital deaths: Confirmed via a structured telephone follow-up conducted on Day 28 of enrollment.
The telephone follow-up will use a standardized questionnaire and will be conducted by trained study coordinators.
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From the date of randomization through Day 28 (±2 days)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to first targeted therapy
大体时间：From the date of randomization through Day 28 (±2 days)
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The time interval (in hours) from the time of enrollment to the first use of an antimicrobial agent effective against the final confirmed pathogen (based on conventional culture or clinical diagnosis).Calculated precisely by comparing the time of antibiotic prescription execution with the time of the final microbiology report.
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From the date of randomization through Day 28 (±2 days)
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Rate of adequate initial treatment
大体时间：From the date of randomization through Day 28 (±2 days)
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The proportion of empirical antimicrobial regimens initiated within 24 hours of enrollment whose antimicrobial spectrum covers the ultimately identified pathogen.Conducted by infectious disease specialists based on the final microbiological diagnosis and antimicrobial susceptibility testing results.
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From the date of randomization through Day 28 (±2 days)
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Length of stay in the ICU
大体时间：From the subject's admission to the ICU until their discharge from the ICU
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Length of stay in the ICU.Extracted directly from discharge records in the hospital information system, accurate to the day.
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From the subject's admission to the ICU until their discharge from the ICU
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Total length of stay
大体时间：From the subject's admission to the hospital until their final discharge
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Total length of stay.Extracted directly from discharge records in the hospital information system, accurate to the day.
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From the subject's admission to the hospital until their final discharge
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Number of days without ventilator or vasoactive drug support
大体时间：During the 28-day observation period, every day
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Calculated based on cumulative daily organ support records over the 28-day observation period.
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During the 28-day observation period, every day
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SOFA Rating
大体时间：During the 28-day observation period, every day
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Calculate the SOFA score daily and record any new or worsening cases of organ failure.The higher the SOFA score, the higher the incidence of multiple organ dysfunction syndrome (MODS); conversely, the lower the score, the lower the incidence.
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During the 28-day observation period, every day
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Total medical expenses
大体时间：On the day of discharge from the hospital
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Retrieve the total medical costs for patients from enrollment through discharge from the hospital's financial system.
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On the day of discharge from the hospital
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年4月23日
首先提交符合 QC 标准的
2026年5月6日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年5月12日
上次提交的符合 QC 标准的更新
2026年5月6日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- ITJ(ZD)2502
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.