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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
Sponsor: Hellenic Institute for the Study of Sepsis
Summary
The goal of this clinical trial is to demonstrate the clinical benefit of early intervention with meropenem in adult patients of both sexes with suspected infection and risk of sepsis. The primary objective is to evaluate the clinical benefit of a protein called Pancreatic Stone Protein (PSP), which, if elevated, indicates that patient may be at increased risk of developing sepsis. The secondary objectives are to investigate the impact of early antibiotic treatment with meropenem on progression to sepsis, survival and mortality. Researchers will compare meropenem to a placebo (a look-alike substance that contains no drug). Participants will: * Take a single dose of meropenem or a placebo * Be evaluated at designated timepoints post administration until their discharge and, also, on days 28 and 90 post administration, respectively.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
398
Start Date
2026-09
Completion Date
2028-12
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
Meropenem Infusion
There is no other intervention in this clinical study and participation in another clinical study is an exclusion criterion.
Sodium Chloride (NaCl) 0.9 %
There is no other intervention in this clinical study and participation in another clinical study is an exclusion criterion.
Locations (10)
Department of Emergency Medicine, G.Gennimatas Athens General Hospital
Athens, Attica, Greece
Department of Emergency Medicine, ATTIKON University General Hospital
Athens, Attica, Greece
Department of Emergency Medicine, Aghios Panteleimon Nikaia General Hospital
Athens, Attica, Greece
Department of Emergency Medicine, Tzaneion Piraeus General Hospital
Piraeus, Attica, Greece
Department of Emergency Medicine, Ioannina University General Hospital
Ioannina, Ioannina, Greece
Department of Internal Medicine, Syros General Hospital
Ermoupoli, Syros, Cyclades, Greece
Department of Emergency Medicine, AHEPA Thessaloniki University General Hospital
Thessaloniki, Thessaloniki, Greece
Department of Emergency Medicine, G. Papanikolaou Thessaloniki General Hospital
Thessaloniki, Thessaloniki, Greece
Department of Emergency Medicine, Koutlibaneio & Triantafylleio General Hospital of Larissa
Larissa, Thessaly, Greece
1st Department of Internal Medicine, Thriasio Eleusis General Hospital
Elefsina, West Attica, Greece