suPAR to Guide Antibiotics in Emergency Department

• Status: Recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Institute for the Study of Sepsis
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Meropenem

Criteria

Inclusion Criteria:

1. Written informed consent provided by the patient or by their legal representative in case of patients unable to consent

2. Age equal to or above 18 years

3. Male or female gender

4. Clinical suspicion of infection

5. qSOFA equal to 1 point

6. suPAR blood level equal or above 12 ng/ml

Exclusion Criteria:

1. Denial to consent

2. Patients with 2 or 3 qSOFA signs

3. Pregnancy (confirmed by blood or urinary pregnancy test) for female patients of reproductive age

4. Organ transplantation

5. Fully-blown sepsis with overt failing organs necessitating immediate resuscitation as defined by the attending physicians

6. Do not resuscitate decision