NCT03717350

Brief Summary

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. The primary study endpoint will be the comparative efficacy of the early suPAR-guided administration of antibiotics versus standard practice on 28-day mortality.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P50-P75 for phase_2 sepsis

Timeline
Completed

Started Oct 2018

Typical duration for phase_2 sepsis

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

October 27, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

2.8 years

First QC Date

October 20, 2018

Last Update Submit

July 28, 2020

Conditions

Sepsis

Keywords

biomarkerssuPARoutcomeantibiotics

Outcome Measures

Primary Outcomes (1)

  • The efficacy of the applied intervention versus standard practice on the early worsening of the patient.

    The primary study endpoint will be the comparative efficacy of the applied intervention (meropenem 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.

    1 day (24 hours)

Secondary Outcomes (9)

  • Sepsis mortality

    28 days

  • Short-term mortality

    7 days

  • Long-term mortality 1

    60 days

  • Long-term mortality 2

    90 days

  • Infection resolution

    90 days

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

100ml of sodium chloride 0.9% within 15 minutes intravenously

Drug: Placebo

Antibiotic

ACTIVE COMPARATOR

2g of meropenem diluted in 100ml of sodium chloride 0.9% within 15 minutes intravenously

Drug: Meropenem

Interventions

MeropenemDRUG

2g of meropenem diluted in 100ml of sodium chloride 0.9% within 15 minutes intravenously administered once

Also known as: Carbapenem
Antibiotic
PlaceboDRUG

100ml of sodium chloride 0.9% within 15 minutes intravenously once

Also known as: Diluent
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, Attica, 12462, Greece

RECRUITING

1st Department of Internal Medicine of G. GENNIMATAS General Hospital

Athens, 11527, Greece

RECRUITING

3rd Department of Internal Medicine at SOTIRIA General Hospital of Chest Diseases of Athens

Athens, 11527, Greece

RECRUITING

Εmergency Department of Sismanogleion Athens General Hospital

Athens, 15126, Greece

RECRUITING

Department of Internal Medicine, Patras University Hospital

Pátrai, Greece

RECRUITING

Related Publications (4)

  • Giamarellos-Bourboulis EJ, Tsaganos T, Tsangaris I, Lada M, Routsi C, Sinapidis D, Koupetori M, Bristianou M, Adamis G, Mandragos K, Dalekos GN, Kritselis I, Giannikopoulos G, Koutelidakis I, Pavlaki M, Antoniadou E, Vlachogiannis G, Koulouras V, Prekates A, Dimopoulos G, Koutsoukou A, Pnevmatikos I, Ioakeimidou A, Kotanidou A, Orfanos SE, Armaganidis A, Gogos C; Hellenic Sepsis Study Group. Validation of the new Sepsis-3 definitions: proposal for improvement in early risk identification. Clin Microbiol Infect. 2017 Feb;23(2):104-109. doi: 10.1016/j.cmi.2016.11.003. Epub 2016 Nov 14.

    PMID: 27856268BACKGROUND

  • Giamarellos-Bourboulis EJ, Norrby-Teglund A, Mylona V, Savva A, Tsangaris I, Dimopoulou I, Mouktaroudi M, Raftogiannis M, Georgitsi M, Linner A, Adamis G, Antonopoulou A, Apostolidou E, Chrisofos M, Katsenos C, Koutelidakis I, Kotzampassi K, Koratzanis G, Koupetori M, Kritselis I, Lymberopoulou K, Mandragos K, Marioli A, Sunden-Cullberg J, Mega A, Prekates A, Routsi C, Gogos C, Treutiger CJ, Armaganidis A, Dimopoulos G. Risk assessment in sepsis: a new prognostication rule by APACHE II score and serum soluble urokinase plasminogen activator receptor. Crit Care. 2012 Aug 8;16(4):R149. doi: 10.1186/cc11463.

    PMID: 22873681BACKGROUND

  • Adami ME, Kotsaki A, Antonakos N, Giannitsioti E, Chalvatzis S, Saridaki M, Avgoustou C, Akinosoglou K, Dakou K, Damoraki G, Katrini K, Koufargyris P, Lekakis V, Panagaki A, Safarika A, Eugen-Olsen J, Giamarellos-Bourboulis EJ. qSOFA combined with suPAR for early risk detection and guidance of antibiotic treatment in the emergency department: a randomized controlled trial. Crit Care. 2024 Feb 6;28(1):42. doi: 10.1186/s13054-024-04825-2.

    PMID: 38321472DERIVED

  • Kyriazopoulou E, Poulakou G, Giamarellos-Bourboulis EJ. Biomarkers in sepsis: can they help improve patient outcome? Curr Opin Infect Dis. 2021 Apr 1;34(2):126-134. doi: 10.1097/QCO.0000000000000707.

    PMID: 33534419DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

MeropenemCarbapenems

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycinsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Evangelos Giamarellos-Bourboulis, MD, PhD

    Attikon Hospital

    STUDY CHAIR

Central Study Contacts

Evangelos J Giamarellos-Bourboulis, MD, PhD

CONTACT

+306945521800egiamarel@med.uoa.gr

Charambos Gogos, MD, PhD

CONTACT

+306944799784egogos@med.upatras.gr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Similar appearance of study drug of both arms
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2018

First Posted

October 24, 2018

Study Start

October 27, 2018

Primary Completion

July 31, 2021

Study Completion

August 31, 2021

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

GR(5)