New CRISPR test could speed up sepsis diagnosis and save lives
NCT ID NCT07580001
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will test a new rapid test called NuRapid-CRISPR that uses CRISPR technology to quickly find the germ causing sepsis in ICU patients. The goal is to see if using this test helps doctors choose the right antibiotics faster and reduces deaths within 28 days. About 396 adults with suspected sepsis will take part across multiple hospitals.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NuRapid-CRISPR rapid pathogen detection test
- What this could lead to
- If successful, this test could help doctors identify the cause of sepsis faster and choose the right antibiotics sooner, potentially saving lives in the ICU.
- What could go wrong
- This is an early-stage study that hasn't started recruiting yet. The test may not prove faster or more accurate than current methods, and results may not apply to all hospitals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 396 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Center for Critical Care Medicine, Tongji Hospital, Shanghai
Shanghai, China
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Shanghai Dongfang Hospital
Shanghai, China
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Yangpu District Central Hospital, Shanghai
Shanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Persistent inflammation, immunosuppression and catabolism syndrome (PICS): a new horizon for surgical critical care subtitle: cardiac dysfunction in older sepsis survivors subtitle: development of a designer Proline-Rich antimicrobial peptide chaperone protein inhibitor (DPC) for treating sepsis
- A randomized clinical trial of early empiric Anti-Mycobacterium tuberculosis therapy for sepsis in Sub-Saharan africa
- Tracing of real-time glu13Cose metabolism in human immune cells - intensive care unit
- Could a neck vein check replace a harder ultrasound for ICU fluid management?
- Sepsis alert system aims to speed up critical care response in hospitals
- Can tracking ambulance ventilators improve emergency breathing care?