A clinical trial for a guided early administration of antibiotics for presumed infection at the ER

A SUPAR GUIDED DOUBLE BLIND RANDOMIZED CLINICAL TRIAL OF INITIATION OF ANTIBIOTICS FOR PRESUMED INFECTION AT THE EMERGENCY DEPARTMENT: THE SUPERIOR TRIAL - SUPERIOR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001008-13-GR

Enrollment

220

Registered

2018-05-15

Start date

2018-07-09

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

? suPAR guided early antibiotic administration at the Emergency Room for presumed infection and sepsis and evaluation of the impact of this intervention to the patients’ final outcome MedDRA version: 20.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: MERONEM PD.I.S.INF 1000MG/VIAL(IV) BTx10 VIALS Pharmaceutical Form: Powder for solution for injection/infusion Pharmaceutical form of the placebo: Infusion Route of administration of the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Written informed consent provided by the patient or by their legal representative in case of patients unable to consent Age equal to or above 18 years Male or female gender Clinical suspicion of infection qSOFA equal to 1 point suPAR blood level equal or above 12 ng/ml Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110

Exclusion criteria

Exclusion criteria: Denial to consent Patients with 2 or 3 qSOFA signs Pregnancy (confirmed by blood or urinary pregnancy test) for female patients of reproductive age Organ transplantation Fully-blown sepsis with overt failing organs necessitating immediate resuscitation as defined by the attending physicians Do not resuscitate decision

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the current study is to evaluate suPAR - guided medical intervention, consisting of early antibiotic administration at the emergency room for presumed infection and sepsis and evaluate the impact of this intervention to the patients’ final outcome. Since the traditionally used biomarkers (PCT, CRP) and scores (SOFA score) for early recognition of severity of infection fail to achieve maximum accuracy in all cases, suPAR levels are assessed as a probably better prognostic rule for early recognition of severe infections.;Secondary Objective: Not applicable;Primary end point(s): The primary study endpoint will be the comparative efficacy of the applied intervention versus standard practice on the early worsening of the patient. This is defined as any at least one point increase of the admission total SOFA score the first 24 hours.;Timepoint(s) of evaluation of this end point: 24 hours	—

Measure

Time frame

Main Objective: The aim of the current study is to evaluate suPAR - guided medical intervention, consisting of early antibiotic administration at the emergency room for presumed infection and sepsis and evaluate the impact of this intervention to the patients’ final outcome. Since the traditionally used biomarkers (PCT, CRP) and scores (SOFA score) for early recognition of severity of infection fail to achieve maximum accuracy in all cases, suPAR levels are assessed as a probably better prognostic rule for early recognition of severe infections.;Secondary Objective: Not applicable;Primary end point(s): The primary study endpoint will be the comparative efficacy of the applied intervention versus standard practice on the early worsening of the patient. This is defined as any at least one point increase of the admission total SOFA score the first 24 hours.;Timepoint(s) of evaluation of this end point: 24 hours

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Secondary

Measure	Time frame
Secondary end point(s): The comparative efficacy of the applied intervention versus standard practice on: The early worsening of the patient defined as for the primary endpoint but analyzed separately per quartile of the total SOFA score of the patient population 7-day, 28-day, 60-day and 90-day mortality 28-day mortality for patients meeting the Sepsis-3 definition of sepsis Time to infection resolution Change of initial treatment Duration of hospitalization Rate of new infections within the following 90 days ;Timepoint(s) of evaluation of this end point: 7,28,60, 90 days	—

Measure

Time frame

Secondary end point(s): The comparative efficacy of the applied intervention versus standard practice on: The early worsening of the patient defined as for the primary endpoint but analyzed separately per quartile of the total SOFA score of the patient population 7-day, 28-day, 60-day and 90-day mortality 28-day mortality for patients meeting the Sepsis-3 definition of sepsis Time to infection resolution Change of initial treatment Duration of hospitalization Rate of new infections within the following 90 days ;Timepoint(s) of evaluation of this end point: 7,28,60, 90 days

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Countries

Greece

Contacts

Public ContactKIRIAKI KANELLAKOPOULOU

HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS

insepsis@otenet.gr+30210 74 80 662

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026