Evaluation of biomArkers for Quick SEpsis Diagnosis - ErASED Study

NCT07655154 | Not Yet Recruiting

• 1 other identifier: ERASED study
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment, in one years

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 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Paolo Sacchi

CONTACT

0382.502198; p.sacchi@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 17, 2026

Record last verified: 2026-05

Locations

IT (1)