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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

keskiviikko 6. toukokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

396

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

  • Nimi: Du Yingying, Doctor
  • Puhelinnumero: +862166111524
  • Sähköposti: dyy9522@163.com

Opiskelupaikat

  • Kiina
      • Shanghai, Kiina
        • Shanghai Dongfang Hospital
        • Ottaa yhteyttä:
      • Shanghai, Kiina
        • Center for Critical Care Medicine, Tongji Hospital, Shanghai
        • Ottaa yhteyttä:
          • Du Yingying, Doctor
          • Puhelinnumero: +862166111524
          • Sähköposti: dyy9522@163.com
      • Shanghai, Kiina
        • Yangpu District Central Hospital, Shanghai
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Lapsi
  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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;

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Diagnostiikka
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Diagnostinen testi: NuRapid-CRISPR Rapid Pathogen Detection Technology
Adjusting early-stage treatment based on NuRapid-CRISPR results.
Active Comparator: 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.
Diagnostinen testi: Traditional pathogen culture
Primarily based on traditional cultivation methods or empirical treatment.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
28-day all-cause mortality rate
Aikaikkuna: 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)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Time to first targeted therapy
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Shanghai 10th People's Hospital

Yhteistyökumppanit

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

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 23. huhtikuuta 2026

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Ensimmäinen Lähetetty (Todellinen)

Tiistai 12. toukokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 12. toukokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

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Viimeksi vahvistettu

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