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

Sponsor
Shanghai 10th People's Hospital
Study ID
NCT07580001
Status
Not Yet Recruiting

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Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 12, 2026
Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
396 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.
  • 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.

Primary Outcome Measure

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

Central Contacts

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