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Evaluating the Diagnostic Performance and Impact on Clinical Outcomes of the NuRapid-CRISPR Pathogen Profile Assay in ICU Patients With Sepsis

6 mei 2026 bijgewerkt door: 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:

  1. 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.
  2. 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

396

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Du Yingying, Doctor
  • Telefoonnummer: +862166111524
  • E-mail: dyy9522@163.com

Studie Locaties

  • China
      • Shanghai, China
      • Shanghai, China
        • Center for Critical Care Medicine, Tongji Hospital, Shanghai
        • Contact:
          • Du Yingying, Doctor
          • Telefoonnummer: +862166111524
          • E-mail: dyy9522@163.com
      • Shanghai, China
        • Yangpu District Central Hospital, Shanghai
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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;

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Diagnostische toets: NuRapid-CRISPR Rapid Pathogen Detection Technology
Adjusting early-stage treatment based on NuRapid-CRISPR results.
Actieve vergelijker: 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.
Diagnostische toets: Traditional pathogen culture
Primarily based on traditional cultivation methods or empirical treatment.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
28-day all-cause mortality rate
Tijdsspanne: From the date of randomization through Day 28 (±2 days)
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.
From the date of randomization through Day 28 (±2 days)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to first targeted therapy
Tijdsspanne: From the date of randomization through Day 28 (±2 days)
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.
From the date of randomization through Day 28 (±2 days)
Rate of adequate initial treatment
Tijdsspanne: From the date of randomization through Day 28 (±2 days)
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.
From the date of randomization through Day 28 (±2 days)
Length of stay in the ICU
Tijdsspanne: From the subject's admission to the ICU until their discharge from the ICU
Length of stay in the ICU.Extracted directly from discharge records in the hospital information system, accurate to the day.
From the subject's admission to the ICU until their discharge from the ICU
Total length of stay
Tijdsspanne: From the subject's admission to the hospital until their final discharge
Total length of stay.Extracted directly from discharge records in the hospital information system, accurate to the day.
From the subject's admission to the hospital until their final discharge
Number of days without ventilator or vasoactive drug support
Tijdsspanne: During the 28-day observation period, every day
Calculated based on cumulative daily organ support records over the 28-day observation period.
During the 28-day observation period, every day
SOFA Rating
Tijdsspanne: During the 28-day observation period, every day
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.
During the 28-day observation period, every day
Total medical expenses
Tijdsspanne: On the day of discharge from the hospital
Retrieve the total medical costs for patients from enrollment through discharge from the hospital's financial system.
On the day of discharge from the hospital

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai 10th People's Hospital

Medewerkers

Shanghai Tongji Hospital, Tongji University School of Medicine
Yangpu District Central Hospital Affiliated to Tongji University
Dongfang Hospital Affiliated to Tongji University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 december 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

23 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

6 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ITJ(ZD)2502

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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