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NOT YET RECRUITING
NCT07813767
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

Meropenem Infusion

There is no other intervention in this clinical study and participation in another clinical study is an exclusion criterion.

DRUG

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