2025-525006-37-00
Recruiting
Phase 3
THE ROLE OF PANCREATIC STONE PROTEIN (PSP) AND PSP-GUIDED EARLY MEROPENEM TREATMENT TO MITIGATE SEPSIS RISK AT THE EMERGENCY DEPARTMENT: THE PROMISE DOUBLE BLIND, PHASE III, RANDOMIZED CONTROLLED CLINICAL TRIAL
Elliniko Institouto Meletis Tis Sipsis0 sites398 target enrollmentStarted: June 1, 2026Last updated:
ConditionsInfection and sepsis
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Elliniko Institouto Meletis Tis Sipsis
- Enrollment
- 398
Overview
Brief Summary
The aim of the PROMISE RCT is to demonstrate how early intervention with single dose meropenem in patients with suspicion of infection at risk of death may improve outcome. In PROMISE, early intervention is guided by the presence of only one sign of the qSOFA score or of NEWS2 score equal to 5/6 together with blood PSP ≥300 ng/ml.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent
- •Adult (≥ 18 years) patients of both sexes.
- •Suspicion of infection defined as the presence of at least one of: Fever defined as core temperature ≥380 C , Tachycardia defined as more than 90 heart beats/min ,Acute presence of any of: shortness of breath or dysuria, or diarrhea or abdominal pain,Complaints that according to investigator’s discretion indicate/are correlated with the presence of infection
- •Presence of either a) one of qSOFA signs (mental confusion, systolic blood pressure less than 100mmHg, respiratory rate more than 22 breaths/min) OR b) NEWS2 equal to 5 or 6 (see Appendices I and II). It is explicitly stated that patients with 0 qSOFA signs may be enrolled in the study if the NEWS2 is 5 or
- •It is also explicitly stated that patients with NEWS2 less than 5 may be enrolled in the study if qSOFA is equal to one.
- •PSP ≥300ng/ml
Exclusion Criteria
- •Deny to consent
- •Documented acute organ dysfunction compatible with sepsis, as reflected by an increase in SOFA-2 score by ≥2 points.
- •Age less than 18 years
- •Patients with nil signs of qSOFA
- •Patients with two or three qSOFA signs
- •Pregnancy (confirmed by blood or urinary pregnancy test that will be conducted after the signing of the consent form at the emergency department) for female patients of reproductive age or lactation
- •Full-blown sepsis with overt organ dysfunction (defined as need of high flow oxygen or mechanical ventilation or vasopressors)
- •Hypersensitivity to meropenem, or to any other antibacterial agent that includes meropenem. Severe hypersensitivity to any antibacterial agent belonging to beta lactam class (eg. penicillins or cephalosporins).
- •Patients receiving probenecid, valproic acid or warfarin.
Investigators
President of the Board
Scientific
Elliniko Institouto Meletis Tis Sipsis
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