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

Phase 1

• 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: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-001008-13-GR
• Lead Sponsor: HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-15
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 220

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified