Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a blood protein flag sepsis before it strikes?

NCT ID NCT07813767

Prevention Sponsor: Hellenic Institute for the Study of Sepsis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether a protein called Pancreatic Stone Protein (PSP) can identify emergency room patients with infection who are at risk of developing sepsis. Adults with suspected infection receive either a single dose of the antibiotic meropenem or a placebo. The trial tracks survival and organ function over 28 and 90 days to see if early treatment helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
meropenem, an antibiotic given as an infusion
What this could lead to
If it works, this could give emergency doctors a fast blood test to spot sepsis risk and a way to treat it before organs are damaged.
What could go wrong
Sepsis is complex and a single early antibiotic dose may not stop it. The trial may show no benefit, and antibiotics carry risks like allergic reactions and resistant infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 398 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Sepsis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 1st Department of Internal Medicine, Thriasio Eleusis General Hospital

    Elefsina, West Attica, 190 18, Greece

  • Department of Emergency Medicine, AHEPA Thessaloniki University General Hospital

    Thessaloniki, Thessaloniki, 54636, Greece

  • Department of Emergency Medicine, ATTIKON University General Hospital

    Athens, Attica, 124 61, Greece

  • Department of Emergency Medicine, Aghios Panteleimon Nikaia General Hospital

    Athens, Attica, 18454, Greece

  • Department of Emergency Medicine, G. Papanikolaou Thessaloniki General Hospital

    Thessaloniki, Thessaloniki, 570 10, Greece

  • Department of Emergency Medicine, G.Gennimatas Athens General Hospital

    Athens, Attica, 115 27, Greece

  • Department of Emergency Medicine, Ioannina University General Hospital

    Ioannina, Ioannina, 455 00, Greece

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

    Larissa, Thessaly, 412 21, Greece

  • Department of Emergency Medicine, Tzaneion Piraeus General Hospital

    Piraeus, Attica, 18535, Greece

  • Department of Internal Medicine, Syros General Hospital

    Ermoupoli, Syros, Cyclades, 841 00, Greece

More trials for these conditions

Other studies related to the condition(s) this trial covers.