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.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
396
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Du Yingying, Doctor
- 電話番号：+862166111524
- メール：dyy9522@163.com
研究場所
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Shanghai、中国
- Shanghai Dongfang Hospital
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コンタクト：
- Zhu Feng
- 電話番号：+86 18801780080
- メール：alexzhufeng@tongji.edu.cn
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Shanghai、中国
- Center for Critical Care Medicine, Tongji Hospital, Shanghai
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コンタクト：
- Du Yingying, Doctor
- 電話番号：+862166111524
- メール：dyy9522@163.com
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Shanghai、中国
- Yangpu District Central Hospital, Shanghai
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コンタクト：
- Shi Bin
- 電話番号：+86 18918288036
- メール：Joysb1969@sina.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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;
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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28-day all-cause mortality rate
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to first targeted therapy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2028年12月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年4月23日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年5月6日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ITJ(ZD)2502
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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