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New test combo could slash unnecessary antibiotic use in sepsis

NCT ID NCT05909683

Knowledge-focused Sponsor: Hellenic Institute for the Study of Sepsis Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using rapid, advanced lab tests to identify the exact bacteria causing a severe infection can help doctors choose the right antibiotics faster. About 190 adults with sepsis in Greek ICUs will either get standard care or the new testing strategy. The goal is to reduce the number of days patients need strong, broad-spectrum antibiotics.

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 190 people

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

Started

Sep 2023

Expected to finish

Apr 2026

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: * Male or female * For women of child-bearing potential, willingness to avoid pregnancy during the study and agreement to notify investigator if pregnancy occurs. * Age more than or equal to 18 years * Patients who have completed their participation in another study for more than 30 days can be included in this study. * Written informed consent provided by the patient or by their legal representative in case of patients unable to consent due to sepsis onset affecting their mental capacity. * Sepsis defined by the Sepsis-3 definition; this is defined separately for community-acquired sepsis and for hospital-acquired sepsis. Community-acquired sepsis is defined as any SOFA score 2 points or more for patients admitted in hospital emergencies with community-acquired pneumonia (CAP), community-acquired acute pyelonephritis (AP) or community-acquired primary bacteremia (BSI). CAP, AP and BSI are considered community-acquired for patients who have no history of hospitalization lasting more than 2 days the last 90 days or who are not under hemodialysis or who are not residents of long-term care facilities. Hospital-acquired sepsis is defined as any SOFA score increase by 2 points or more from the admission SOFA score for patients with onset of hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acute pyelonephritis (AP) or primary bacteremia (BSI) at least 48 hours after hospital admission. For patients with history of hospitalization lasting more than 2 days the last 90 days or who are under hemodialysis or who are residents of long-term care facilities and are admitted to hospital with HAP, VAP, AP and BSI the definition of hospital-acquired sepsis applies. In this case, the baseline SOFA score is considered as the known SOFA score before infection onset. * Presence of one of the following infections: community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acute pyelonephritis (AP) and primary bacteremia (BSI). * Positive blood culture Exclusion Criteria: * Failure to obtain written consent to participate * Previous enrollment in this study within the past 90 days. Patients enrolled in another study will not be accepted. * Patients in pregnancy or breastfeeding. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study * Patients receiving prolonged antibiotic therapies (e.g. endocarditis, implantable device-associated infection, cerebral/hepatic abscess, osteomyelitis, meningitis) * Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.) * Patients with infection due to Mycobacterium tuberculosis. * Patients suffering from cystic fibrosis * Severely immunocompromised patients such as a) patients with infection by the human immunodeficiency virus and with a CD4 count of less than 200 cells/mm3; b) neutropenic patients with less than 500 neutrophils/mm3; and c) patients with solid organ transplantation.

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Conditions

The condition(s) this trial relates to.

acute pyelonephritis bacterial infectious disease with sepsis Infections infectious disease with sepsis nosocomial infection pneumonia Sepsis

As listed by the trial registrant

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

Sepsis

Contacts and locations

Locations

  • 1st Department of Internal Medicine - General Hospital of Athens Sismanoglio- Amalia Fleming

    Athens, 15126, Greece

  • 1st Department of Internal Medicine, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S.

    Athens, 11526, Greece

  • 1st Department of Internal Medicine, General Hospital of Elefsina "Thriasio"

    Athens, Elefsina, 19600, Greece

  • 1st Department of Internal Medicine- General Hospital of Athens GENNIMATAS

    Athens, 11527, Greece

  • 1st University Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 54636, Greece

  • 2nd Department of Internal Medicine, General Hospital of Piraeus "Tzaneio"

    Piraeus, 18536, Greece

  • 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis

    Alexandroupoli, Greece

  • 2nd Propaedeutic Department of Internal Medicine, Attikon University Hospital

    Athens, Chaidari, 12462, Greece

  • 3rd Department of Internal Medicine - General State Hospital of Nikaia "Saint Panteleimon" - West Attica General Hospital "Agia Varvara"

    Athens, 18454, Greece

  • 3rd University Department of Internal Medicine, Sotiria Athens General Hospital

    Athens, 11527, Greece

  • 4th Department of Internal Medicine, Attikon University Hospital

    Athens, Chaidari, 12462, Greece

  • Clinic of Intensive Care and Pulmonary Diseases, Aghioi Anargyroi Kifissia General Oncologic Hospital

    Kifissia, 14564, Greece

  • Intensive Care Unit of Center for Respiratory Failure, Sotiria Chest Diseases Athens General Hospital

    Athens, Attica, 11527, Greece

  • Intensive Care Unit, Ippokrateion General Hospital

    Thessaloniki, 54642, Greece

  • New Multivalent Intensive Care Unit, Sotiria Chest Diseases Athens General Hospital

    Athens, Attica, 11527, Greece

More trials for these conditions

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