SepsisNCT07822412
PRIME Sepsis Trial: Early Sepsis Detection in the Emergency Department Using Presepsin and Immature Granulocytes
An observational study of Sepsis and Septic Shock, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 699 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2026to Apr 2029
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Department of Emergency Medicine, New Taipei Municipal Tucheng Hospital
New Taipei City, 23652
Chen June Seak, +886-975-365-802, julianseak@hotmail.com
About this study
Official title: PRIME-Sepsis Trial: Presepsin and Immature Granulocytes for Multicenter Early Sepsis Detection in the Emergency Department: A Prospective Observational Study
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.
Read the detailed description
Sepsis is characterized by a dysregulated host inflammatory response to infection, potentially leading to multiple organ dysfunction syndrome (MODS) and death. Globally, the estimated annual incidence of sepsis ranges from 18 to 31.5 million cases, with mortality rates as high as 30%. Approximately 70% of sepsis patients are initially managed in the emergency department (ED). Although delayed recognition and treatment are associated with poorer outcomes, and early evidence-based intervention significantly improves survival , early identification of sepsis in the ED remains a formidable clinical challenge . Despite the critical need for prompt intervention, research indicates that the detection of infection is often delayed by more than 4 hours after hospital admission and by over 8 hours in approximately 30% of ED cases.
Diverse biomarkers have been proposed to facilitate timely diagnosis, risk stratification, and the initiation of appropriate treatment. Complete blood count (CBC) parameters are particularly advantageous in the ED due to their rapid turnaround time, low cost, and repeatability. Traditionally, white blood cell (WBC) count and immature granulocyte (IG) count have served as first-line indicators. Advanced hematology technologies now provide detailed morphologic data (e.g., cell volume and structural changes), potentially enhancing the diagnostic value of these parameters. While IG has been recognized as a marker of systemic inflammation and sepsis, its clinical utility remains a subject of ongoing debate. Specifically, some studies suggest limited predictive value for long-term outcomes such as 28-day mortality, leading to inconsistent conclusions regarding its diagnostic reliability when used in isolation for the detection of sepsis.
Recent investigations into IG for ED sepsis diagnosis have reported areas under the receiver operating characteristic curve (AUC) ranging from 0.52 to 0.93. This pronounced variability is likely attributable to differences in study methodologies and patient populations. Concurrently, Presepsin (soluble CD14 subtype, sCD14-ST) has emerged as a promising alternative biomarker. Presepsin is generated via monocyte activation and pathogen phagocytosis, resulting in a rapid surge in circulating levels during the incipient immune response. Evidence suggests that Presepsin rises earlier than conventional biomarkers and correlates strongly with sepsis severity and clinical outcomes. Specifically, Presepsin has demonstrated superior or comparable diagnostic performance to C-reactive protein (CRP) and procalcitonin (PCT) in emergency settings.
Previous investigations have consistently demonstrated the superior diagnostic performance of Presepsin, with reported Area Under the Receiver Operating Characteristic curve (AUROC) values often exceeding 0.90 in both emergency sepsis presentations and complex postoperative infectious settings, supporting its role as a benchmark biomarker for early infection detection.
In the PRIME-Sepsis Trial (Presepsin and Immature Granulocytes for Multicenter Early Sepsis Detection), we aim to evaluate the synergistic diagnostic accuracy of integrating IG and Presepsin for identifying sepsis in adult patients with a high clinical suspicion of infection in the ED. While Presepsin offers superior diagnostic potential in the hyper-acute phase, IG provides a readily available, cost-effective reflection of the systemic hematopoietic response. By synergizing these complementary biomarkers, our primary objective is to assess the incremental diagnostic yield of a combined molecular-cellular model against multiple reference standards (Sepsis-2, Sepsis-3, and qSOFA). This approach will enable us to derive and evaluate a novel dual-parameter diagnostic algorithm, ultimately facilitating earlier clinical decision-making and improving prognostic accuracy in diverse emergency care settings. This prospective, multicenter design minimizes the biases inherent in previous retrospective analyses, providing a more robust foundation for clinical implementation.
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Emergency Department, Presepsin, Immature Granulocytes, Diagnostic Accuracy, Clinical Protocol
- Medical subject headings
- Sepsis, Shock, Septic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: At enrollment (Time 0 / Emergency Department presentation)
Secondary outcomes (4)
Prognostic Value of Presepsin for Predicting Septic Shock Development
Evaluation of the capability of Presepsin (measured in pg/mL) to predict progression from early sepsis to septic shock. The prognostic performance will be analyzed by calculating the AUROC, sensitivity, specificity, positive predictive value, and negative predictive value.
Measured: Through 30 days after enrollment
Prognostic Value of Immature Granulocytes for Predicting Septic Shock Development
Evaluation of the capability of immature granulocytes (IG, measured in percentage) to predict progression from early sepsis to septic shock. The prognostic performance will be analyzed by calculating the AUROC, sensitivity, specificity, positive predictive value, and negative predictive value.
Measured: Through 30 days after enrollment
Concentration of Presepsin for Predicting 30-Day All-Cause Mortality
Concentration of Presepsin (measured in pg/mL) used to assess the 30-day all-cause mortality rate post-enrollment. The prognostic performance will be evaluated by calculating the Area Under the Receiver Operating Characteristic curve (AUROC) and the Odds Ratio (OR) derived from multiple logistic regression analysis to determine the predictive capability of Presepsin for 30-day mortality.
Measured: 30 days post-enrollment
Percentage of Immature Granulocytes for Predicting 30-Day All-Cause Mortality
Percentage of immature granulocytes (measured in percentage, %) used to assess the 30-day all-cause mortality rate post-enrollment. The prognostic performance will be evaluated by calculating the Area Under the Receiver Operating Characteristic curve (AUROC) and the Odds Ratio (OR) derived from multiple logistic regression analysis to determine the predictive capability of immature granulocytes for 30-day mortality.
Measured: 30 days post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 699 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi Jui Lin, Study chair, Department of Medical Laboratory, New Taipei Municipal Tucheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822412
- Sponsor's protocol ID
- 202600705B0
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
White IR, Royston P, Wood AM. Multiple imputation using chained equations: Issues and guidance for practice. Stat Med. 2011 Feb 20;30(4):377-99. doi: 10.1002/sim.4067. Epub 2010 Nov 30.
PubMed 21225900Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
PubMed 34599691Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making. 2006 Nov-Dec;26(6):565-74. doi: 10.1177/0272989X06295361.
PubMed 17099194Hanley JA, McNeil BJ. A method of comparing the areas under receiver operating characteristic curves derived from the same cases. Radiology. 1983 Sep;148(3):839-43. doi: 10.1148/radiology.148.3.6878708.
PubMed 6878708Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology. 1982 Apr;143(1):29-36. doi: 10.1148/radiology.143.1.7063747.
PubMed 7063747Yao S, Kaido T, Uozumi R, Hirata M, Iwamura S, Miyachi Y, Macshut M, Sharshar M, Yagi S, Uemoto S. Diagnostic potential of presepsin in bacterial infection following hepato-biliary-pancreatic surgery: A prospective observational study. J Hepatobiliary Pancreat Sci. 2020 Oct;27(10):756-766. doi: 10.1002/jhbp.802. Epub 2020 Aug 21.
PubMed 32654388Ruan L, Chen GY, Liu Z, Zhao Y, Xu GY, Li SF, Li CN, Chen LS, Tao Z. The combination of procalcitonin and C-reactive protein or presepsin alone improves the accuracy of diagnosis of neonatal sepsis: a meta-analysis and systematic review. Crit Care. 2018 Nov 21;22(1):316. doi: 10.1186/s13054-018-2236-1.
PubMed 30463590Piccioni A, Baroni S, Rozzi G, Belvederi F, Leggeri S, Spagnuolo F, Novelli M, Pignataro G, Candelli M, Covino M, Gasbarrini A, Franceschi F. Evaluation of Presepsin for Early Diagnosis of Sepsis in the Emergency Department. J Clin Med. 2025 Apr 4;14(7):2480. doi: 10.3390/jcm14072480.
PubMed 40217929Yaegashi Y, Shirakawa K, Sato N, Suzuki Y, Kojika M, Imai S, Takahashi G, Miyata M, Furusako S, Endo S. Evaluation of a newly identified soluble CD14 subtype as a marker for sepsis. J Infect Chemother. 2005 Oct;11(5):234-8. doi: 10.1007/s10156-005-0400-4.
PubMed 16258819Chenevier-Gobeaux C, Borderie D, Weiss N, Mallet-Coste T, Claessens YE. Presepsin (sCD14-ST), an innate immune response marker in sepsis. Clin Chim Acta. 2015 Oct 23;450:97-103. doi: 10.1016/j.cca.2015.06.026. Epub 2015 Jul 9.
PubMed 26164388Paraskevas T, Chourpiliadi C, Demiri S, Micahilides C, Karanikolas E, Lagadinou M, Velissaris D. Presepsin in the diagnosis of sepsis. Clin Chim Acta. 2023 Oct 1;550:117588. doi: 10.1016/j.cca.2023.117588. Epub 2023 Oct 7.
PubMed 37813329Jeon K, Lee N, Jeong S, Park MJ, Song W. Immature granulocyte percentage for prediction of sepsis in severe burn patients: a machine leaning-based approach. BMC Infect Dis. 2021 Dec 16;21(1):1258. doi: 10.1186/s12879-021-06971-2.
PubMed 34915849Ha SO, Park SH, Park SH, Park JS, Huh JW, Lim CM, Koh Y, Hong SB, Jang S. Fraction of immature granulocytes reflects severity but not mortality in sepsis. Scand J Clin Lab Invest. 2015 Jan;75(1):36-43. doi: 10.3109/00365513.2014.965736. Epub 2014 Oct 24.
PubMed 25342241Karon BS, Tolan NV, Wockenfus AM, Block DR, Baumann NA, Bryant SC, Clements CM. Evaluation of lactate, white blood cell count, neutrophil count, procalcitonin and immature granulocyte count as biomarkers for sepsis in emergency department patients. Clin Biochem. 2017 Nov;50(16-17):956-958. doi: 10.1016/j.clinbiochem.2017.05.014. Epub 2017 May 25.
PubMed 28552399Hwang YJ, Chung SP, Park YS, Chung HS, Lee HS, Park JW, Lee JW, Hong JH, You JS, Park I. Newly designed delta neutrophil index-to-serum albumin ratio prognosis of early mortality in severe sepsis. Am J Emerg Med. 2015 Nov;33(11):1577-82. doi: 10.1016/j.ajem.2015.06.012. Epub 2015 Jun 14.
PubMed 26238097
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIME-Sepsis Trial: Presepsin and Immature Granulocytes for Multicenter Early Sepsis Detection in the Emergency Department: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07822412
- Acronym / sponsor ID
- 202600705B0
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Emergency Department, Presepsin, Immature Granulocytes, Diagnostic Accuracy, Clinical Protocol
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 699 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sepsis is characterized by a dysregulated host inflammatory response to infection, potentially leading to multiple organ dysfunction syndrome (MODS) and death. Globally, the estimated annual incidence of sepsis ranges from 18 to 31.5 million cases, with mortality rates as high as 30%. Approximately 70% of sepsis patients are initially managed in the emergency department (ED). Although delayed recognition and treatment are associated with poorer outcomes, and early evidence-based intervention significantly improves survival , early identification of sepsis in the ED remains a formidable clinical challenge . Despite the critical need for prompt intervention, research indicates that the detection of infection is often delayed by more than 4 hours after hospital admission and by over 8 hours in approximately 30% of ED cases.
Diverse biomarkers have been proposed to facilitate timely diagnosis, risk stratification, and the initiation of appropriate treatment. Complete blood count (CBC) parameters are particularly advantageous in the ED due to their rapid turnaround time, low cost, and repeatability. Traditionally, white blood cell (WBC) count and immature granulocyte (IG) count have served as first-line indicators. Advanced hematology technologies now provide detailed morphologic data (e.g., cell volume and structural changes), potentially enhancing the diagnostic value of these parameters. While IG has been recognized as a marker of systemic inflammation and sepsis, its clinical utility remains a subject of ongoing debate. Specifically, some studies suggest limited predictive value for long-term outcomes such as 28-day mortality, leading to inconsistent conclusions regarding its diagnostic reliability when used in isolation for the detection of sepsis.
Recent investigations into IG for ED sepsis diagnosis have reported areas under the receiver operating characteristic curve (AUC) ranging from 0.52 to 0.93. This pronounced variability is likely attributable to differences in study methodologies and patient populations. Concurrently, Presepsin (soluble CD14 subtype, sCD14-ST) has emerged as a promising alternative biomarker. Presepsin is generated via monocyte activation and pathogen phagocytosis, resulting in a rapid surge in circulating levels during the incipient immune response. Evidence suggests that Presepsin rises earlier than conventional biomarkers and correlates strongly with sepsis severity and clinical outcomes. Specifically, Presepsin has demonstrated superior or comparable diagnostic performance to C-reactive protein (CRP) and procalcitonin (PCT) in emergency settings.
Previous investigations have consistently demonstrated the superior diagnostic performance of Presepsin, with reported Area Under the Receiver Operating Characteristic curve (AUROC) values often exceeding 0.90 in both emergency sepsis presentations and complex postoperative infectious settings, supporting its role as a benchmark biomarker for early infection detection.
In the PRIME-Sepsis Trial (Presepsin and Immature Granulocytes for Multicenter Early Sepsis Detection), we aim to evaluate the synergistic diagnostic accuracy of integrating IG and Presepsin for identifying sepsis in adult patients with a high clinical suspicion of infection in the ED. While Presepsin offers superior diagnostic potential in the hyper-acute phase, IG provides a readily available, cost-effective reflection of the systemic hematopoietic response. By synergizing these complementary biomarkers, our primary objective is to assess the incremental diagnostic yield of a combined molecular-cellular model against multiple reference standards (Sepsis-2, Sepsis-3, and qSOFA). This approach will enable us to derive and evaluate a novel dual-parameter diagnostic algorithm, ultimately facilitating earlier clinical decision-making and improving prognostic accuracy in diverse emergency care settings. This prospective, multicenter design minimizes the biases inherent in previous retrospective analyses, providing a more robust foundation for clinical implementation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of Presepsin for Early Sepsis Screening
Time frame: At enrollment (Time 0 / Emergency Department presentation)
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).
Diagnostic Accuracy of Immature Granulocytes for Early Sepsis Screening
Time frame: At enrollment (Time 0 / Emergency Department presentation)
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).
4 secondary outcomes
Prognostic Value of Presepsin for Predicting Septic Shock Development
Time frame: Through 30 days after enrollment
Prognostic Value of Immature Granulocytes for Predicting Septic Shock Development
Time frame: Through 30 days after enrollment
Concentration of Presepsin for Predicting 30-Day All-Cause Mortality
Time frame: 30 days post-enrollment
Percentage of Immature Granulocytes for Predicting 30-Day All-Cause Mortality
Time frame: 30 days post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 21225900White IR, Royston P, Wood AM. Multiple imputation using chained equations: Issues and guidance for practice. Stat Med. 2011 Feb 20;30(4):377-99. doi: 10.1002/sim.4067. Epub 2010 Nov 30.
- Background: PubMed 34599691Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
- Background: PubMed 17099194Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making. 2006 Nov-Dec;26(6):565-74. doi: 10.1177/0272989X06295361.
- Background: PubMed 6878708Hanley JA, McNeil BJ. A method of comparing the areas under receiver operating characteristic curves derived from the same cases. Radiology. 1983 Sep;148(3):839-43. doi: 10.1148/radiology.148.3.6878708.
- Background: PubMed 7063747Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology. 1982 Apr;143(1):29-36. doi: 10.1148/radiology.143.1.7063747.
- Background: PubMed 32654388Yao S, Kaido T, Uozumi R, Hirata M, Iwamura S, Miyachi Y, Macshut M, Sharshar M, Yagi S, Uemoto S. Diagnostic potential of presepsin in bacterial infection following hepato-biliary-pancreatic surgery: A prospective observational study. J Hepatobiliary Pancreat Sci. 2020 Oct;27(10):756-766. doi: 10.1002/jhbp.802. Epub 2020 Aug 21.
- Background: PubMed 30463590Ruan L, Chen GY, Liu Z, Zhao Y, Xu GY, Li SF, Li CN, Chen LS, Tao Z. The combination of procalcitonin and C-reactive protein or presepsin alone improves the accuracy of diagnosis of neonatal sepsis: a meta-analysis and systematic review. Crit Care. 2018 Nov 21;22(1):316. doi: 10.1186/s13054-018-2236-1.
- Background: PubMed 40217929Piccioni A, Baroni S, Rozzi G, Belvederi F, Leggeri S, Spagnuolo F, Novelli M, Pignataro G, Candelli M, Covino M, Gasbarrini A, Franceschi F. Evaluation of Presepsin for Early Diagnosis of Sepsis in the Emergency Department. J Clin Med. 2025 Apr 4;14(7):2480. doi: 10.3390/jcm14072480.
- Background: PubMed 16258819Yaegashi Y, Shirakawa K, Sato N, Suzuki Y, Kojika M, Imai S, Takahashi G, Miyata M, Furusako S, Endo S. Evaluation of a newly identified soluble CD14 subtype as a marker for sepsis. J Infect Chemother. 2005 Oct;11(5):234-8. doi: 10.1007/s10156-005-0400-4.
- Background: PubMed 26164388Chenevier-Gobeaux C, Borderie D, Weiss N, Mallet-Coste T, Claessens YE. Presepsin (sCD14-ST), an innate immune response marker in sepsis. Clin Chim Acta. 2015 Oct 23;450:97-103. doi: 10.1016/j.cca.2015.06.026. Epub 2015 Jul 9.
- Background: PubMed 37813329Paraskevas T, Chourpiliadi C, Demiri S, Micahilides C, Karanikolas E, Lagadinou M, Velissaris D. Presepsin in the diagnosis of sepsis. Clin Chim Acta. 2023 Oct 1;550:117588. doi: 10.1016/j.cca.2023.117588. Epub 2023 Oct 7.
- Background: PubMed 34915849Jeon K, Lee N, Jeong S, Park MJ, Song W. Immature granulocyte percentage for prediction of sepsis in severe burn patients: a machine leaning-based approach. BMC Infect Dis. 2021 Dec 16;21(1):1258. doi: 10.1186/s12879-021-06971-2.
- Individual participant dataSharing planned: Undecided
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Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi Jui Lin study chair
Department of Medical Laboratory, New Taipei Municipal Tucheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen June Seak, M.D (+886-975-365-802, julianseak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Presepsin for Early Sepsis Screening (time frame: At enrollment (Time 0 / Emergency Department presentation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07822412, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.