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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Elliniko Institouto Meletis Tis Sipsis

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Decision date (initial)

2026-04-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacoeconomic

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.

Conditions and MedDRA coding

Infection and sepsis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Written informed consent
2. Adult (≥ 18 years) patients of both sexes.
3. 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
4. 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 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.
5. PSP ≥300ng/ml

Exclusion criteria 10

1. Deny to consent
2. Age less than 18 years
3. Patients with nil signs of qSOFA
4. Patients with two or three qSOFA signs
5. 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
6. NEWS2 ≥ 7
7. Full-blown sepsis with overt organ dysfunction (defined as need of high flow oxygen or mechanical ventilation or vasopressors)
8. 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).
9. Patients receiving probenecid, valproic acid or warfarin.
10. Documented acute organ dysfunction compatible with sepsis, as reflected by an increase in SOFA-2 score by ≥2 points.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of this study is 28-day mortality, defined as death from any cause occurring within 28 days after randomization. The aim is to evaluate if early administration of antibiotics guided by early sepsis detection with the device under investigation is associated with a reduction in short-term mortality compared to the control group. Survival is censored at day 28 since this is globally recognized as the survival censoring point in all sepsis trials.

Secondary endpoints 9

1. The key secondary endpoint is the progression into organ dysfunction defined as increases of total SOFA-2 score by 2 or more points the first 24 hours. The aim is to evaluate if early administration of antibiotics guided by early sepsis detection with the device under investigation is associated with a reduction in progression into organ dysfunction compared to the control group.
2. Comparative changes of the total SOFA-2 scores by the first 48 and 96 hours.
3. Time to stop of antibiotics (defined as treatment started at the discretion of the attending physicians)
4. Rate of hospitalization
5. Time to hospital discharge alive
6. 90-day mortality
7. Kinetics of PSP over-time and per type of infection
8. Rate of resistant fecal flora
9. Primary endpoint, key secondary endpoint and all secondary endpoints for patients classified into infections after adjudication

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Elliniko Institouto Meletis Tis Sipsis

Sponsor organisation

Elliniko Institouto Meletis Tis Sipsis

Address

Laodikias 17

City

Athens

Postcode

115 28

Country

Greece

Scientific contact point

Organisation

Elliniko Institouto Meletis Tis Sipsis

Contact name

President of the Board

Public contact point

Organisation

Elliniko Institouto Meletis Tis Sipsis

Contact name

President of the Board

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 27 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications