New CRISPR test could speed up sepsis diagnosis and save lives

NCT ID NCT07580001

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 396 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Center for Critical Care Medicine, Tongji Hospital, Shanghai

    Shanghai, China

  • Shanghai Dongfang Hospital

    Shanghai, China

  • Yangpu District Central Hospital, Shanghai

    Shanghai, China

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