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

NCT07580001 | Not Yet Recruiting DMC

• 1 other identifier: ITJ(ZD)2502
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 3

Brief Summary

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. 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. 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.

Conditions

Sepsis

Keywords

Sepsis; Pathogen Detection Technologies

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (7)

• Time to first targeted therapy

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

• Rate of adequate initial treatment

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

• Length of stay in the ICU

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

• Total length of stay

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

• Number of days without ventilator or vasoactive drug support

  During the 28-day observation period, every day

Study Arms (2)

NuRapid-CRISPR

EXPERIMENTAL

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.

Diagnostic Test: NuRapid-CRISPR Rapid Pathogen Detection Technology

Pathogen culture

ACTIVE COMPARATOR

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.

Diagnostic Test: Traditional pathogen culture

Interventions

Traditional pathogen culture DIAGNOSTIC_TEST

Primarily based on traditional cultivation methods or empirical treatment.

Pathogen culture

NuRapid-CRISPR Rapid Pathogen Detection Technology DIAGNOSTIC_TEST

Adjusting early-stage treatment based on NuRapid-CRISPR results.

NuRapid-CRISPR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead
• Yangpu District Central Hospital Affiliated to Tongji University: collaborator
• Dongfang Hospital Affiliated to Tongji University: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator

Study Sites (3)

Center for Critical Care Medicine, Tongji Hospital, Shanghai

Shanghai, China

Location

Shanghai Dongfang Hospital

Shanghai, China

Location

Yangpu District Central Hospital, Shanghai

Shanghai, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Du Yingying, Doctor

CONTACT

+862166111524; dyy9522@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Center for Critical Care Medicine, Tongji Hospital, Shanghai

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)