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New score could help doctors spot fungal pneumonia faster

NCT ID NCT07681583

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study aims to create and test a clinical prediction score called FUNGAL-P to help doctors identify fungal pneumonia early in adults who come to the hospital with pneumonia. Researchers will analyze medical records from past patients and then test the score on new patients to see how well it works. The goal is to improve early diagnosis and guide timely treatment for this serious lung infection.

What this could mean

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

What this could lead to
If successful, this prediction score could help doctors diagnose fungal pneumonia earlier, leading to faster treatment and better outcomes for patients.
What could go wrong
This is an observational study, not a treatment trial. The score may not perform as well in other hospitals or patient groups, and it needs further validation before widespread use.

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 400 people

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

Started

Nov 2025

Expected to finish

Nov 2031

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

Adult patients presenting with pneumonia at Careggi University Hospital who underwent microbiological evaluation of lower respiratory tract samples, including bronchoalveolar lavage, bronchial aspirate, or endotracheal aspirate, within 48 hours of hospital presentation. The study population includes patients with microbiologically confirmed fungal, bacterial, or viral pneumonia enrolled in retrospective and prospective cohorts for derivation and validation of the FUNGAL-P clinical prediction score.

Ages

18 to 90 years

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: * Age ≥18 years and ≤90 years. * Presentation to the Emergency Department or hospital with pneumonia. * Pneumonia defined according to IDSA/ATS criteria as the presence of at least two clinical signs or symptoms of lower respiratory tract infection (temperature \<36.0°C or \>38.0°C, respiratory rate \>20 breaths/min, oxygen saturation \<90% on room air, arterial PaO₂ \<60 mmHg, cough, sputum production, white blood cell count \<4,000/μL or \>10,000/μL, or bandemia \>10%) together with radiographic evidence of a new pulmonary infiltrate or cavitary lesion. * Bronchoalveolar lavage (BAL), bronchial aspirate (BAS), or endotracheal aspirate (ETA) performed within 48 hours of hospital presentation. * Modified Rankin Scale score \<5. * Availability of microbiological investigations for identification of fungal, bacterial, or viral pathogens. * Provision of informed consent, when required by applicable regulations and ethics committee approval. Exclusion Criteria: * Refusal or withdrawal of informed consent. * Age \<18 years or \>90 years. * Pregnancy. * Expected life expectancy \<3 months. * Hospital-acquired pneumonia with onset \>48 hours after hospital admission. * Modified Rankin Scale score ≥5. * Absence of microbiological diagnostic evaluation. * No identified bacterial, fungal, or viral pathogen after microbiological investigations.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Careggi University Hospital

    RECRUITING

    Florence, Italy

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