Evaluating the Diagnostic Performance and Impact on Clinical Outcomes of the NuRapid-CRISPR Pathogen Profile Assay in ICU Patients With Sepsis
2026년 5월 6일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
396
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Du Yingying, Doctor
- 전화번호: +862166111524
- 이메일: dyy9522@163.com
연구 장소
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Shanghai, 중국
- Shanghai Dongfang Hospital
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연락하다:
- Zhu Feng
- 전화번호: +86 18801780080
- 이메일: alexzhufeng@tongji.edu.cn
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Shanghai, 중국
- Center for Critical Care Medicine, Tongji Hospital, Shanghai
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연락하다:
- Du Yingying, Doctor
- 전화번호: +862166111524
- 이메일: dyy9522@163.com
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Shanghai, 중국
- Yangpu District Central Hospital, Shanghai
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연락하다:
- Shi Bin
- 전화번호: +86 18918288036
- 이메일: Joysb1969@sina.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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;
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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28-day all-cause mortality rate
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to first targeted therapy
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2028년 12월 1일
연구 완료 (추정된)
2028년 12월 1일
연구 등록 날짜
최초 제출
2026년 4월 23일
QC 기준을 충족하는 최초 제출
2026년 5월 6일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 6일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ITJ(ZD)2502
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
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