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 study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
General Hospital Of Eleusina Thriasio Eleusina Greece
General Hospital Of Larissa Koutlibaneio And Triantafylleio Larissa Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
University General Hospital Of Ioannina Ioannina Greece
Geniko Nosokomeio Peiraia Tzaneio Piraeus Greece
Gpmzxj Nvyaztxfko Nwoiwxk Pnmsodu Ajz Pkmsddtsgvz Gqnfps Nlhmmiugmb Ddkouzw Afywmjr I Νikaia Greece
Gsohjgn Hhgjzctd ot Shvxv Syros Greece
Lkcvq Gsvcgym Hngupojh Og Aaaiuq Athens Greece
Utmlrwbbrq Gesohpy Hxkcmdtv Arbeobi Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Not yet recruiting
01.06.2026

Trial locations

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

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 ID:
2025-525006-37-00
Protocol code:
PROMISE
Trial Phase:
Therapeutic confirmatory (Phase III)

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