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New blood marker could help doctors catch sepsis days sooner

NCT ID NCT07232784

Diagnosis Sponsor: Fapon Biotech Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looked at whether measuring a protein called PSP in the blood can help doctors recognize sepsis earlier in ICU patients at high risk. Researchers enrolled 250 adults in China, taking daily blood samples until sepsis was diagnosed or ruled out. The goal was to see if PSP levels could predict sepsis up to three days before standard diagnosis, potentially leading to faster treatment and better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pancreatic stone protein (PSP) blood test
What this could lead to
If successful, this could give doctors a new tool to diagnose sepsis days earlier, allowing quicker treatment and potentially saving lives.
What could go wrong
This is an observational study, not a treatment trial. The test may not prove accurate enough in real-world settings, and results from 250 patients in China may not apply to all ICU populations.

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.

Participants

250 people

The number who actually took part.

Started

Jul 2024

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

ICU admitted patients at high-risk of developing sepsis

Ages

18 years and older

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: 1. ICU patients over 18 years old； 2. Patients at high risk of sepsis in any of the following: 1. History of recent surgery or invasive medical procedures; 2. Pneumonia, complicated urinary tract infections, abdominal infections, central nervous system infections, etc.; 3. Severe trauma: such as the percentage of total body surface area (TBSA) burned \> 15%, or serious traffic accident injuries, etc.; 3. Expected ICU stay for more than 4 days； 4. Have provided written informed consent or consent is given by the patient's legally designated representative. Exclusion Criteria: 1. Patients diagnosed with sepsis; 2. Patients expected to die within 48 hours of admission to ICU； 3. Pregnancy； 4. Patient suffering from or known acute or chronic pancreatitis, pancreatic cancer or admitted after pancreatectomy; but if a patient develops any pancreatic disease during the ICU stay, he/she will remain in the study； 5. Patients with SOFA score \< 2 but who have undergone blood purification; 6. Unable or unwilling to provide the required blood sample for testing； 7. Patients with unclear medical record information; 8. Patients with mental disorders and other disorders who cannot correctly understand informed consent; 9. Patients who subjectively refused to be enrolled in the study or who were judged not to be enrolled by the investigator.

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adult patients at high risk of sepsis

Contacts and locations

Locations

  • Shenzhen Third People's Hospital

    Shenzhen, Guangdong, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, China

  • Zhuhai People's Hospital

    Zhuhai, Guangdong, China

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