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

N/ANot Yet RecruitingNCT07580001

Shanghai 10th People's Hospital396 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

396

Conditions

Sepsis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

28-day all-cause mortality rate

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.

Time frame: From the date of randomization through Day 28 (±2 days)

Secondary Outcomes

Time to first targeted therapy

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.

Time frame: From the date of randomization through Day 28 (±2 days)

Rate of adequate initial treatment

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.

Time frame: From the date of randomization through Day 28 (±2 days)

Length of stay in the ICU

Length of stay in the ICU.Extracted directly from discharge records in the hospital information system, accurate to the day.

Time frame: From the subject's admission to the ICU until their discharge from the ICU

Total length of stay

Total length of stay.Extracted directly from discharge records in the hospital information system, accurate to the day.

Time frame: From the subject's admission to the hospital until their final discharge

Number of days without ventilator or vasoactive drug support

Calculated based on cumulative daily organ support records over the 28-day observation period.

Time frame: During the 28-day observation period, every day

SOFA Rating

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.

Time frame: During the 28-day observation period, every day

Total medical expenses

Retrieve the total medical costs for patients from enrollment through discharge from the hospital's financial system.

Time frame: On the day of discharge from the hospital

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts