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

Official title

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

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.

Interventions

• Diagnostic test NuRapid-CRISPR Rapid Pathogen Detection Technology
  Adjusting early-stage treatment based on NuRapid-CRISPR results.
• Diagnostic test Traditional pathogen culture
  Primarily based on traditional cultivation methods or empirical treatment.

Primary outcome measures

• 28-day all-cause mortality rate [Time frame: From the date of randomization through Day 28 (±2 days)]

Secondary outcome measures (7)

• Time to first targeted therapy [Time frame: From the date of randomization through Day 28 (±2 days)]
• Rate of adequate initial treatment [Time frame: From the date of randomization through Day 28 (±2 days)]
• Length of stay in the ICU [Time frame: From the subject's admission to the ICU until their discharge from the ICU]
• Total length of stay [Time frame: From the subject's admission to the hospital until their final discharge]
• Number of days without ventilator or vasoactive drug support [Time frame: During the 28-day observation period, every day]
• SOFA Rating [Time frame: During the 28-day observation period, every day]
• Total medical expenses [Time frame: On the day of discharge from the hospital]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

China · 3 centers

• Center for Critical Care Medicine, Tongji Hospital, Shanghai — Shanghai
• Shanghai Dongfang Hospital — Shanghai
• Yangpu District Central Hospital, Shanghai — Shanghai

Identifiers

NCT: NCT07580001 · ITJ(ZD)2502

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗