Evaluating the Diagnostic Performance and Impact on Clinical Outcomes of the NuRapid-CRISPR Pathogen Profile Assay in ICU Patients With Sepsis
6 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Тип исследования
Интервенционный
Регистрация (Оцененный)
396
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Du Yingying, Doctor
- Номер телефона: +862166111524
- Электронная почта: dyy9522@163.com
Места учебы
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Shanghai, Китай
- Shanghai Dongfang Hospital
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Контакт:
- Zhu Feng
- Номер телефона: +86 18801780080
- Электронная почта: alexzhufeng@tongji.edu.cn
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Shanghai, Китай
- Center for Critical Care Medicine, Tongji Hospital, Shanghai
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Контакт:
- Du Yingying, Doctor
- Номер телефона: +862166111524
- Электронная почта: dyy9522@163.com
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Shanghai, Китай
- Yangpu District Central Hospital, Shanghai
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Контакт:
- Shi Bin
- Номер телефона: +86 18918288036
- Электронная почта: Joysb1969@sina.com
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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;
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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28-day all-cause mortality rate
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Time to first targeted therapy
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 июля 2026 г.
Первичное завершение (Оцененный)
1 декабря 2028 г.
Завершение исследования (Оцененный)
1 декабря 2028 г.
Даты регистрации исследования
Первый отправленный
23 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
6 мая 2026 г.
Первый опубликованный (Действительный)
12 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
12 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
6 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ITJ(ZD)2502
Планирование данных отдельных участников (IPD)
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ДА
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .