AuthorisedTherapeutic confirmatory (Phase III)Interventional

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

This important study, called PROMISE, aims to find out if using a new test to spot sepsis early, combined with giving an antibiotic called Meronem, can improve the chances of survival for people with serious infections. Sepsis is a life-threatening condition caused by the body's overwhelming response to an infection. Researchers are comparing this new approach against the usual treatment in a large group of emergency department patients. They will specifically look at how many people are still alive 28 days after treatment starts. The study hopes to show that earlier, guided antibiotic treatment could lead to better outcomes for patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Elliniko Institouto Meletis Tis Sipsis

Enrolment target

398

Start

29 Apr 2026

Infection and sepsis

What is this study about?

When you have a serious infection, your body can sometimes react in a way that leads to a life-threatening condition called sepsis. Sepsis needs to be treated very quickly, often with antibiotics, to give you the best chance of recovery. This study, called PROMISE, is looking at a new way to help doctors decide more quickly if someone is developing sepsis and if they would benefit from an antibiotic called Meronem right away.

The main goal of the study is to see if giving Meronem early, based on the results of a new test (which looks at something called Pancreatic Stone Protein or PSP), can reduce the number of people who die within 28 days of starting treatment. They will compare this new method to the standard care usually given in the emergency department.

Beyond saving lives, the study will also check other important things. For example, it will see if this early treatment can stop organs (like your heart or kidneys) from being damaged by the infection. It will also look at how quickly people recover, how long they stay in hospital, and their health after 90 days. The information from this study could help doctors across the UK and beyond to treat sepsis more effectively in the future.

Key takeaways

This study investigates early antibiotic treatment for sepsis.
It uses a new test to help doctors spot sepsis quickly.
The main goal is to improve survival rates for patients.
It compares a new treatment approach to standard care.
Participation involves receiving either Meronem or a salt-water solution.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

More detailed information about specific health conditions or medications that might prevent someone from joining isn't available in this summary. However, a doctor or nurse working on the study would carefully check if it's safe and appropriate for you to take part.

The study is generally for people who arrive at the emergency department with signs of a serious infection that could lead to sepsis.

Quick self-check

Are you 18 years old or older?
Are you arriving at the emergency department with signs of a serious infection?
Are you currently suffering from a severe infection that might lead to sepsis?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would receive either the antibiotic Meronem or a salt-water solution (called Sodium Chloride) through a drip. Which one you receive is decided randomly, like flipping a coin, and neither you nor your doctors will know which one you are getting to ensure fair results. The Meronem is given as a powder mixed into a solution for injection or drip.

Throughout the study, doctors and nurses will monitor your health closely. This will include regular checks, possibly blood tests, and looking at how your condition changes. They will also track how long it takes for you to leave the hospital and your health for up to 90 days after starting treatment. The main focus will be on your health 28 days after you start the study treatment. The total duration of your participation will depend on your recovery, but your health will be tracked for up to 90 days.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. You might benefit from closer monitoring and potentially an earlier, more effective treatment for your infection. However, there's also a chance you could experience side effects from the antibiotic or the study treatments, although these will be carefully managed. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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Greece

Common questions

What is sepsis?

Sepsis is a serious and life-threatening condition when your body's immune system overreacts to an infection.

What is Meronem?

Meronem is a strong antibiotic used to treat serious bacterial infections.

Will I know if I'm getting Meronem or the other treatment?

No, in this type of study, neither you nor your doctors will know which treatment you are getting to keep the results fair.

What is the new test for sepsis?

The study uses a new test that looks at something called Pancreatic Stone Protein (PSP) to help detect sepsis earlier.

How long will the study track my health?

The study will track your health for up to 90 days after you start treatment, with a main focus on your health after 28 days.