Evaluating the Diagnostic Performance and Impact on Clinical Outcomes of the NuRapid-CRISPR Pathogen Profile Assay in ICU Patients With Sepsis
6 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Tipo di studio
Interventistico
Iscrizione (Stimato)
396
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Du Yingying, Doctor
- Numero di telefono: +862166111524
- Email: dyy9522@163.com
Luoghi di studio
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Shanghai, Cina
- Shanghai Dongfang Hospital
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Contatto:
- Zhu Feng
- Numero di telefono: +86 18801780080
- Email: alexzhufeng@tongji.edu.cn
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Shanghai, Cina
- Center for Critical Care Medicine, Tongji Hospital, Shanghai
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Contatto:
- Du Yingying, Doctor
- Numero di telefono: +862166111524
- Email: dyy9522@163.com
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Shanghai, Cina
- Yangpu District Central Hospital, Shanghai
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Contatto:
- Shi Bin
- Numero di telefono: +86 18918288036
- Email: Joysb1969@sina.com
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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;
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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28-day all-cause mortality rate
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time to first targeted therapy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 luglio 2026
Completamento primario (Stimato)
1 dicembre 2028
Completamento dello studio (Stimato)
1 dicembre 2028
Date di iscrizione allo studio
Primo inviato
23 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
6 maggio 2026
Primo Inserito (Effettivo)
12 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ITJ(ZD)2502
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .