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

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;