PRIME Sepsis Trial: Early Sepsis Detection in the Emergency Department Using Presepsin and Immature Granulocytes

NCT07822412 | Not Yet Recruiting DMC

• 1 other identifier: 202600705B0
• Study Type: observational
• Target: 699
• Locations: 1 country
• Sites: 1

Brief Summary

Early identification and timely intervention for sepsis in the emergency department (ED) are critical for improving patient outcomes. However, clinical diagnosis remains challenging due to the non-specific nature of early systemic symptoms. This study protocol aims to evaluate the diagnostic accuracy of a combined approach using Immature Granulocytes (IG) and Presepsin (sCD14-ST) for the early detection of sepsis in undifferentiated ED patients.

Conditions

Sepsis; Septic Shock

Keywords

Sepsis; Emergency Department; Presepsin; Immature Granulocytes; Diagnostic Accuracy; Clinical Protocol

Outcome Measures

Primary Outcomes (2)

• Diagnostic Accuracy of Presepsin for Early Sepsis Screening

  The diagnostic performance of Presepsin (measured in pg/mL) will be evaluated using the Area Under the Receiver Operating Characteristic curve (AUROC). The AUROC will be analyzed to evaluate the ability of Presepsin to differentiate patients with sepsis from those with non-infectious systemic inflammatory response syndrome (SIRS).

  At enrollment (Time 0 / Emergency Department presentation)

• Diagnostic Accuracy of Immature Granulocytes for Early Sepsis Screening

  The diagnostic performance of immature granulocytes (IG, measured in percentage) will be evaluated using the Area Under the Receiver Operating Characteristic curve (AUROC). The AUROC will be analyzed to evaluate the ability of IG to differentiate patients with sepsis from those with non-infectious systemic inflammatory response syndrome (SIRS).

  At enrollment (Time 0 / Emergency Department presentation)

Secondary Outcomes (4)

• Prognostic Value of Presepsin for Predicting Septic Shock Development

  Through 30 days after enrollment

• Prognostic Value of Immature Granulocytes for Predicting Septic Shock Development

  Through 30 days after enrollment

• Concentration of Presepsin for Predicting 30-Day All-Cause Mortality

  30 days post-enrollment

• Percentage of Immature Granulocytes for Predicting 30-Day All-Cause Mortality

  30 days post-enrollment

Study Arms (1)

Suspected Sepsis Cohort

This is a purely observational study. Peripheral blood samples are collected at enrollment (T0) solely for the laboratory measurement of Presepsin and immature granulocytes (IG). This process does not alter, delay, or interfere with standard clinical diagnosis, management, or treatment decisions in the emergency department.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age: Adult patients (≥ 18 years old) presenting to the EDs of the participating sites.
• 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.
• Feasibility of Biomarker Collection: Ability to obtain blood samples for IG and Presepsin measurement within 2 hours of ED arrival.
• Informed Consent: Provision of written informed consent obtained from the patient or their legally authorized representative (LAR).

You may not qualify if:

• 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.
• Hematological Conditions: Documented hematological malignancies or myelodysplastic syndromes (MDS) capable of altering baseline IG profiles.
• Pregnancy or lactation, due to the potential for pregnancy-induced physiological and immunological variability.
• 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.
• Consent Issues: Refusal to provide informed consent by the patient or their LAR.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Emergency Medicine, New Taipei Municipal Tucheng Hospital

New Taipei City, 23652, Taiwan

Location

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and plasma samples will be collected and retained from patients with suspected sepsis at the emergency department. These specimens will be used for central laboratory testing to measure biomarkers, including Presepsin and immature granulocytes (IG), to evaluate their diagnostic and prognostic performance.

MeSH Terms

Conditions

Sepsis; Shock, Septic; Emergencies

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Officials

• Chi Jui Lin

  Department of Medical Laboratory, New Taipei Municipal Tucheng Hospital

  STUDY CHAIR

Central Study Contacts

Chen June Seak, M.D

CONTACT

+886-975-365-802; julianseak@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-05

Locations

TW (1)