Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorAzienda Ospedaliero-Universitaria Careggi

About this trial

The FUNGAL-P study is a single-center observational study designed to derive and validate a clinical prediction score for the early identification of fungal pneumonia in adult patients presenting with pneumonia.

The study includes a retrospective derivation cohort and a prospective validation cohort of patients undergoing microbiological evaluation of lower respiratory tract samples. Clinical, laboratory, radiological, microbiological, and treatment-related variables associated with fungal pneumonia will be analyzed to identify independent predictors of fungal infection. These predictors will be combined to develop the FUNGAL-P score.

The derived score will subsequently be evaluated in a prospective validation cohort to assess its diagnostic performance, calibration, and clinical utility. The ultimate goal is to facilitate earlier recognition of fungal pneumonia and support timely diagnostic testing and antifungal treatment in patients presenting to the Emergency Department or hospital with pneumonia.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Refusal or withdrawal of informed consent.

Age <18 years or >90 years.

Pregnancy.

Expected life expectancy <3 months.

Trial design

Treatments tested in this trial

  • FUNGAL-P Score Assessment

Treatment groups

400 Participants
are divided into 2 treatment groups