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Can two blood markers catch sepsis before it turns deadly?

NCT ID NCT07822412

Diagnosis Sponsor: Chang Gung Memorial Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Sepsis is hard to spot early because its first symptoms look like many other conditions. Researchers at emergency departments in Taiwan are studying whether two blood markers, presepsin and immature granulocytes, can help doctors tell sepsis apart from other causes of inflammation. The study enrolls about 699 adults who arrive at the emergency department with a suspected infection and signs of systemic inflammation. Doctors will draw blood and compare the marker levels between patients who turn out to have sepsis and those who do not.

What this could mean

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

Active substance
a blood test measuring presepsin and immature granulocytes
What this could lead to
If the blood markers prove accurate, emergency doctors could identify sepsis sooner and start treatment before the condition worsens.
What could go wrong
This observational study only measures how well the markers perform. The markers may not separate sepsis from other inflammatory conditions reliably, and the results may not apply to every hospital or patient group.

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

About 699 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

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.

Who is studied

The study population consists of adult patients (aged 18 years and older) who present to the emergency department of participating multi-center medical institutions with a suspected or confirmed infection and exhibit clinical signs suggestive of early 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. Age: Adult patients (≥ 18 years old) presenting to the EDs of the participating sites. 2. Clinical Suspicion of Infection: A high clinical suspicion of infection as determined by the attending emergency physician, accompanied by either a Systemic Inflammatory Response Syndrome (SIRS) score ≥ 2 or a Quick Sequential Organ Failure Assessment (qSOFA) score ≥ 2. Rationale: This dual-criteria strategy (SIRS or qSOFA) reflects a pragmatic, high-sensitivity approach designed to capture the full spectrum of sepsis in the emergency setting, overcoming the sensitivity limitations of using a single scoring system. 3. Feasibility of Biomarker Collection: Ability to obtain blood samples for IG and Presepsin measurement within 2 hours of ED arrival. 4. Informed Consent: Provision of written informed consent obtained from the patient or their legally authorized representative (LAR). Exclusion Criteria: 1. Severe Immunosuppression: Active chemotherapy, history of organ transplantation, or long-term high-dose corticosteroid therapy that may confound leukocyte kinetics or suppress systemic inflammatory responses. 2. Hematological Conditions: Documented hematological malignancies or myelodysplastic syndromes (MDS) capable of altering baseline IG profiles. 3. Pregnancy or lactation, due to the potential for pregnancy-induced physiological and immunological variability. 4. Prolonged Prior Hospitalization: Patients transferred from another facility after an admission of \>24 hours, as extensive prior intervention may obscure the hyper-acute biomarker kinetics critical for early diagnosis. 5. Consent Issues: Refusal to provide informed consent by the patient or their LAR.

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Conditions

The condition(s) this trial relates to.

Emergencies infectious disease with sepsis Sepsis toxic shock syndrome

As listed by the trial registrant

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

Sepsis Septic shock

How to take part

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  1. The places running it

    1 site. 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

  • Department of Emergency Medicine, New Taipei Municipal Tucheng Hospital

    New Taipei City, 23652, Taiwan

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