Evaluation of biomArkers for Quick SEpsis Diagnosis - ErASED Study

June 12, 2026 updated by: Paolo Sacchi, Fondazione IRCCS Policlinico San Matteo di Pavia

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 Overview

Status

Not yet recruiting

Conditions

Sepsis

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Paolo Sacchi
Phone Number: 0382.502198
Email: p.sacchi@smatteo.pv.it

Study Locations

Italy
- - Pavia, Italy, 27100
    - Fondazione IRCCS Policlinico San Matteo
    - Contact:
      
      Paolo Sacchi
      
      Phone Number: 0382.502198
      
      Email: p.sacchi@smatteo.pv.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Patients with an history of recent traumatic injury.
Patients who refuse to sign the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment, in one years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

May 14, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)