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

NCT07813767 | Not Yet Recruiting Phase 3

• 3 other identifiers: PROMISE2025-525006-37-002025
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Sepsis

Keywords

Sepsis; PSP; Meropenem; qSOFA; NEWS-2; SOFA-2; PROMISE; Pancreatic Stone Protein

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  All-cause mortality, defined as death from any cause occurring within 28 days after administration of the study intervention.

  28 days after administration of the study intervention

Secondary Outcomes (9)

• Progression to organ dysfunction

  Within 24 hours after administration of the study intervention.

• Change in total SOFA-2 score

  48 and 96 hours after administration of the study intervention.

• Time to stop of antibiotics

  From administration of the study intervention through hospital discharge or Day 28.

• Duration of hospitalization

  From hospital admission through discharge or Day 28.

• Time to hospital discharge alive

  From hospital admission through hospital discharge or Day 28.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Receiving 100 mL of 0.9% NS within 15 minutes of IV infusion

Drug: Sodium Chloride (NaCl) 0.9 %

Meropenem

ACTIVE COMPARATOR

Receiving 2 g of meropenem dissolved into 100 mL of 0.9% NS within 15 minutes of IV infusion

Drug: Meropenem Infusion

Interventions

Meropenem Infusion DRUG

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

Meropenem

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hellenic Institute for the Study of Sepsis: lead

Study Sites (10)

Department of Emergency Medicine, G.Gennimatas Athens General Hospital

Athens, Attica, 115 27, Greece

Location

Department of Emergency Medicine, ATTIKON University General Hospital

Athens, Attica, 124 61, Greece

Location

Department of Emergency Medicine, Aghios Panteleimon Nikaia General Hospital

Athens, Attica, 18454, Greece

Location

Department of Emergency Medicine, Tzaneion Piraeus General Hospital

Piraeus, Attica, 18535, Greece

Location

Department of Emergency Medicine, Ioannina University General Hospital

Ioannina, Ioannina, 455 00, Greece

Location

Department of Internal Medicine, Syros General Hospital

Ermoupoli, Syros, Cyclades, 841 00, Greece

Location

Department of Emergency Medicine, AHEPA Thessaloniki University General Hospital

Thessaloniki, Thessaloniki, 54636, Greece

Location

Department of Emergency Medicine, G. Papanikolaou Thessaloniki General Hospital

Thessaloniki, Thessaloniki, 570 10, Greece

Location

Department of Emergency Medicine, Koutlibaneio & Triantafylleio General Hospital of Larissa

Larissa, Thessaly, 412 21, Greece

Location

1st Department of Internal Medicine, Thriasio Eleusis General Hospital

Elefsina, West Attica, 190 18, Greece

Location

MeSH Terms

Conditions

Sepsis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Evangelos J Giamarellos-Bourboulis, Professor

  Hellenic Institute for the Study of Sepsis

  STUDY CHAIR

Central Study Contacts

Evangelos J Giamarellos-Bourboulis, Professor

CONTACT

2105831994; egiamarel@med.uoa.gr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-10

Locations

GR (10)