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A study to evaluate the use of meropenem to reduce the risk of sepsis in patients with suspected infection in the emergency department

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates the management of infection and sepsis, a life-threatening condition where the body's response to an infection causes widespread damage to its own tissues and organs. The research focuses on whether using a specific protein found in the blood, known as pancreatic stone protein, can help identify patients who are at a high risk of developing severe complications. The study aims to determine if giving the antibiotic meropenem very early in the treatment process can improve patient outcomes.

Participants in the study will be divided into two groups. One group will receive meropenem through an intravenous infusion, which is a method of delivering medication directly into a vein. The other group will receive a placebo consisting of sodium chloride, a common salt solution. This process is conducted as a double-blind trial, meaning neither the patients nor the medical staff know which substance is being administered during the treatment period.

During the course of the study, medical professionals will monitor how the body responds to the treatment. The focus will be on observing survival rates and checking for organ dysfunction, which refers to a situation where vital organs such as the kidneys, liver, or lungs are not working correctly. The study will also track how long patients remain in the hospital and the overall progress of the illness following the administration of the medication.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>randomization</b>

    You will be assigned to one of two groups through a process called randomization, which means the group is chosen by chance, similar to a coin toss.

    This is a double blind study, meaning neither you nor the medical staff will know which treatment is being received during the process.

  2. Step 2

    <b>treatment administration</b>

    If assigned to the test group, you will receive a single dose of meropenem (an antibiotic used to treat bacterial infections) via intravenous infusion. the dose is 2 grams.

    If assigned to the placebo group, you will receive a single dose of sodium chloride (a saline solution) via intravenous infusion. the volume is 100 ml.

  3. Step 3

    <b>monitoring and follow-up</b>

    Medical staff will monitor for organ dysfunction, which is when organs like the kidneys or liver do not function correctly, during the first 24, 48, and 96 hours.

    The status of your health and survival will be tracked for a period of 28 days to evaluate the effectiveness of the treatment.

    Additional monitoring regarding hospitalization and discharge will continue to assess the overall outcome.

Who can join the trial?

9 criteria

  • You must provide written informed consent, which means you agree to participate in the study after being fully informed about all its details.
  • You must be an adult, meaning you are 18 years of age or older.
  • The study is open to both males and females.
  • Doctors must suspect you have an infection, which is when harmful germs enter your body. This suspicion must be based on at least one of the following: a fever (body temperature of 38°C or higher), tachycardia (a fast heart rate of more than 90 beats per minute), or sudden shortness of breath, dysuria (painful urination), diarrhea, or abdominal pain.
  • You must show specific signs of illness measured by medical scoring systems:
  • You may qualify if you show at least one sign of the qSOFA score, which includes mental confusion, systolic blood pressure (the pressure in your arteries when your heart beats) being less than 100mmHg, or a respiratory rate (the number of breaths you take per minute) of more than 22.
  • Alternatively, you may qualify if your NEWS2 score (a system used to track your vital signs) is 5 or 6, even if you have no qSOFA signs.
  • You may also qualify if your qSOFA sign is 1, even if your NEWS2 score is less than 5.
  • You must have a blood PSP level (a specific protein measured in your blood) of 300 ng/ml or higher.

Who cannot join the trial?

11 criteria

  • If you do not give your consent, which means you do not agree to take part in the study.
  • If you have acute organ dysfunction, which means your organs (such as your kidneys, liver, or lungs) are not working correctly right now, as shown by a specific medical score called the SOFA-2 score.
  • If you are under 18 years of age.
  • If you show no signs of qSOFA, which is a quick medical assessment used to check for the risk of serious infection.
  • If you show two or three signs of qSOFA.
  • If you are pregnant, which is confirmed by a blood or urine test, or if you are lactating, which means you are breastfeeding.
  • If your NEWS2 score is 7 or higher; this is a tool used by medical staff to check how unwell a person is.
  • If you have full-blown sepsis with clear signs that your organs are failing, such as needing extra oxygen through a machine, a mechanical ventilator (a machine that breathes for you), or vasopressors (medicines used to raise blood pressure).
  • If you have a hypersensitivity, which is a severe allergy, to meropenem or any other medicine that contains it.
  • If you have a severe allergy to any medicine in the beta lactam class, such as penicillins or cephalosporins.
  • If you are currently taking the medicines probenecid, valproic acid, or warfarin.
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Investigated drugs

Meropenem is an antibiotic used to treat serious bacterial infections by killing the bacteria responsible for the illness.

What is already known about the treatment

  • Meropenem

    This medication is an antibiotic administered as a liquid through an intravenous infusion directly into a vein. It is a widely used and well-established medicine used to treat serious bacterial infections and sepsis. It works by attacking and breaking down the protective outer layers of bacteria, which prevents them from growing and multiplying. This drug belongs to a class of medicines known as carbapenems.

  • Sodium chloride

    This substance is administered as a clear liquid through an intravenous infusion into a vein. In medical practice, it is commonly used as a saline solution to maintain fluid balance in the body. It works by helping to replace lost water and salt, ensuring the body stays hydrated and maintains proper chemical levels. It is pharmacologically classified as an electrolyte solution.

Investigated diseases

Sepsis - This condition occurs when the body's immune response to an infection triggers widespread inflammation throughout the body. As the condition progresses, the intense inflammatory response can lead to damage in various organs. This process can cause organs to stop functioning correctly as the body struggles to manage the infection. The progression is often marked by changes in vital signs and the potential for multi-organ dysfunction.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-525006-37-00Protocol codePROMISEEstimated enrolment398 patientsSponsorHellenic Institute For The Study Of Sepsis

sourced from the EU Clinical Trials Register and site verification

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