SepsisNCT07655154
Evaluation of biomArkers for Quick SEpsis Diagnosis - ErASED Study
An observational study of Sepsis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Since the "Sepsis-3" consensus statement in 2016, sepsis has been defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Recognition of sepsis is mostly based on clinical criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 2 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2026to Sep 2030
- 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 population enrolled in this study will include patients admitted to the Emergency and Internal Medicine Department of Fondazione IRCCS Policlinico San Matteo in Pavia during the study period.
Who may be able to join
- All patients ≥18 years old meeting criteria for organ dysfunction identified as an acute change in total SOFA score ≥2 points.
- At least one collected microbiological sample
- Informed consent signed by patients or legal tutors.
Who cannot join
- Patients with an history of recent traumatic injury.
- Patients who refuse to sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Paolo Sacchi, 0382.502198, p.sacchi@smatteo.pv.it
About this study
Since the "Sepsis-3" consensus statement in 2016, sepsis has been defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Recognition of sepsis is mostly based on clinical criteria. To aid diagnosis, a wide range of biomarkers has been identified, however, with few exceptions such as procalcitonin, none is part of the routine assessment of a septic patient. Proadrenomedullin, serum calprotectin and a score of combined values of IL-6 + IL-8 + IL-10 + MCP-1 have been proposed as biomarkers to aid diagnosis and predict prognosis in sepsis, but data about their kinetics and their correlation to mortality, organ dysfunction and microbiological diagnosis is still lacking. The aim is at prospectically studying their kinetics in clinically septic patients during the first hours of their presentation in our Emergency Department, with the aim of assessing their ability to distinguish sepsis from other causes of life-threatening organ dysfunction and disease severity. Patients will be thus divided in cases (culture-confirmed infection) and controls (patient without demonstrated cause of infection). Secondary objectives will evaluate the correlation between the biomarkers' values, mortality, admission to Intensive Care Unit and organ dysfunction. In patients with confirmed infection, moreover, we will correlate biomarkers with the etiological diagnosis. The expectetion is to be able to enrol at least 120 patients in 12 months. With this number of subjects, it will be possible to detect significant differences in the mean values of the biomarkers with a power of 90% and a type I error of 5%. Analyses will produce summary indicators to synthesize the kinetics of the biomarkers including area under the curve, percentage of time spent over a critical threshold (e.g., the 75th percentile of the values), and variability indicators such as standard deviation and difference between the last and the first value. Time series among groups will be analysed with standard statistical techniques such as repeated ANOVA and advanced temporal clustering techniques. For the secondary objectives will be used the Wilcoxon test with suitable post hoc strategies to correct for multiple comparisons.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the kinetics of preadrenomedullin, serum calprotectin and a score of combined values of IL-6 + IL-8 + IL-10 + MCP-1 collected at time 0, 6, 12, 24 hours (+/- 1hour) in patients with culture-confirmed infection and patient without demonstrat
The procedures required for the study are standard clinical practice and all the microbiological and biochemical samples will be processed according to routine operative procedures except for the biomarkers object of the study (preadrenomedullin, serum calprotectin, IL-6, IL- 8, IL-10, MCP-1), which will be delivered to the Immunology and Allergology laboratory for further processing as detailed below.
Measured: From enrollment to the end of treatment, in one years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Sacchi, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655154
- Sponsor's protocol ID
- ERASED study
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of biomArkers for Quick SEpsis Diagnosis - ErASED Study
- ClinicalTrials.gov ID
- NCT07655154
- Acronym / sponsor ID
- ERASED study
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 17 Jun 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.
Since the "Sepsis-3" consensus statement in 2016, sepsis has been defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Recognition of sepsis is mostly based on clinical criteria. To aid diagnosis, a wide range of biomarkers has been identified, however, with few exceptions such as procalcitonin, none is part of the routine assessment of a septic patient. Proadrenomedullin, serum calprotectin and a score of combined values of IL-6 + IL-8 + IL-10 + MCP-1 have been proposed as biomarkers to aid diagnosis and predict prognosis in sepsis, but data about their kinetics and their correlation to mortality, organ dysfunction and microbiological diagnosis is still lacking. The aim is at prospectically studying their kinetics in clinically septic patients during the first hours of their presentation in our Emergency Department, with the aim of assessing their ability to distinguish sepsis from other causes of life-threatening organ dysfunction and disease severity. Patients will be thus divided in cases (culture-confirmed infection) and controls (patient without demonstrated cause of infection). Secondary objectives will evaluate the correlation between the biomarkers' values, mortality, admission to Intensive Care Unit and organ dysfunction. In patients with confirmed infection, moreover, we will correlate biomarkers with the etiological diagnosis. The expectetion is to be able to enrol at least 120 patients in 12 months. With this number of subjects, it will be possible to detect significant differences in the mean values of the biomarkers with a power of 90% and a type I error of 5%. Analyses will produce summary indicators to synthesize the kinetics of the biomarkers including area under the curve, percentage of time spent over a critical threshold (e.g., the 75th percentile of the values), and variability indicators such as standard deviation and difference between the last and the first value. Time series among groups will be analysed with standard statistical techniques such as repeated ANOVA and advanced temporal clustering techniques. For the secondary objectives will be used the Wilcoxon test with suitable post hoc strategies to correct for multiple comparisons.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population enrolled in this study will include patients admitted to the Emergency and Internal Medicine Department of Fondazione IRCCS Policlinico San Matteo in Pavia during the study period.
Key inclusion criteria (3 listed)
- All patients ≥18 years old meeting criteria for organ dysfunction identified as an acute change in total SOFA score ≥2 points.
- At least one collected microbiological sample
- Informed consent signed by patients or legal tutors.
Key exclusion criteria (2 listed)
- Patients with an history of recent traumatic injury.
- Patients who refuse to sign the informed consent.
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
To compare the kinetics of preadrenomedullin, serum calprotectin and a score of combined values of IL-6 + IL-8 + IL-10 + MCP-1 collected at time 0, 6, 12, 24 hours (+/- 1hour) in patients with culture-confirmed infection and patient without demonstrat
Time frame: From enrollment to the end of treatment, in one years
The procedures required for the study are standard clinical practice and all the microbiological and biochemical samples will be processed according to routine operative procedures except for the biomarkers object of the study (preadrenomedullin, serum calprotectin, IL-6, IL- 8, IL-10, MCP-1), which will be delivered to the Immunology and Allergology laboratory for further processing as detailed below.
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 17 Jun 2026.
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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.
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, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 3 inclusion and 2 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 17 Jun 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 Italy. 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 Paolo Sacchi (0382.502198, p.sacchi@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the kinetics of preadrenomedullin, serum calprotectin and a score of combined values of IL-6 + IL-8 + IL-10 + MCP-1 collected at time 0, 6, 12, 24 hours (+/- 1hour) in patients with culture-confirmed infection and patient without demonstrat (time frame: From enrollment to the end of treatment, in one years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.