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New biomarkers could speed up pneumonia diagnosis in ICU patients

NCT ID NCT05117125

Diagnosis Sponsor: Region Skane Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing whether certain proteins, lung bacteria, and bacterial gene patterns can help predict or diagnose pneumonia in patients on breathing machines. Researchers will measure these biomarkers in 1,000 ICU patients and compare those who develop pneumonia to those who do not. The goal is to find faster, more accurate ways to diagnose ventilator-associated pneumonia.

What this could mean

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

Active substance
Heparin-binding protein, Interleukin-26, lung microbiome analysis, bacterial transcriptome analysis
What this could lead to
If successful, this could lead to faster and more accurate diagnosis of ventilator-associated pneumonia, helping doctors start the right treatment sooner.
What could go wrong
This is an early-stage biomarker study, not a treatment trial. The markers may not prove accurate enough for routine use, and results may not apply to all ICU patients.

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.

Participants

About 1,000 people

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

Started

Oct 2021

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.

Who is studied

General intensive care unit population.

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: * Admission to an intensive care unit * Intubation within last 24 hours * Anticipated mechanical ventilation of at least 48 hours Exclusion Criteria: * FiO2 above 70% or PEEP above 15 * Severe coagulopathy (spontaneous PK(INR) \>1.8 or thrombocytes \<50). Prophylaxis treatment dose of LMWH or factor Xa inhibitors/NOAC is not an exclusion criteria. If higher doses of these substances are administered, the responsible clinician should be consulted before sample collection. * Ongoing infection of the lungs at admission to the ICU. * Severely elevated or instable intracranial pressure.

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Conditions

The condition(s) this trial relates to.

Pneumonia, Ventilator-Associated

As listed by the trial registrant

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

Pneumonia, ventilator-associated

How to take part

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

  1. The places running it

    5 sites in 3 countries. 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

  • Hospital de São Francisco Xavier

    RECRUITING

    Lisbon, Portugal

  • Karolinska University Hospital, ICU

    NOT_YET_RECRUITING

    Solna, Sweden

  • Skåne University Hospital, Dept. of Infectious diseases

    RECRUITING

    Lund, Sweden

  • Skåne university Hospital, ICU

    RECRUITING

    Malmö, Sweden

  • Vestre Viken

    RECRUITING

    Drammen, 3004, Norway

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