RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07813767

Registry updated: 2026-10-19

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Meropenem Infusion (Drug)
There is no other intervention in this clinical study and participation in another clinical study is an exclusion criterion.
Sodium Chloride (NaCl) 0.9 % (Drug)
There is no other intervention in this clinical study and participation in another clinical study is an exclusion criterion.

Eligibility criteria

Inclusion Criteria: * Written informed consent * Adult (≥18 years) patients of both sexes * Infection suspicion defined as the presence of at least one of: i) fever ≥38°C; ii) tachycardia (\>90 beats/min); iii) acute presence of shortness of breath or dysuria, or diarrhea or abdominal pain; and iv) complaints that according to investigator's discretion indicate/are correlated with the presence of infection * Presence of only one of qSOFA signs (mental confusion, systolic blood pressure less than 100mmHg, respiratory rate more than 22 breaths/min) OR NEWS2 equal to 5 or 6. It is explicitly stated that patients with 0 qSOFA signs may be enrolled in the study if the NEWS2 is 5 or 6. 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 ≥300 ng/ml measured at the Triage Exclusion Criteria: * Deny to consent * Age less than 18 years * Presence of nil, two or three signs of qSOFA * NEWS2 ≥7 * Full-blown sepsis with overt organ dysfunction (defined as need of high flow oxygen or mechanical ventilation or vasopressors) * Pregnancy (pregnancy test either blood or uninary will be conducted at the ED for female patients of reproductive age) or lactation * 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. * Documented acute organ dysfunction compatible with sepsis, as reflected by an increase in SOFA-2 score by ≥2 points.

Conditions

Sepsis

Locations

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

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment