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

Recruiting now

Conditions studied: Pneumonia, Fungal Pneumonia, Aspergillosis Pneumonia, Pulmonary Aspergillosis, Pulmonary Aspergillosis Invasive, Pneumocystis, Pneumocystis Pneumonia, Fungal Disease, Fungal Infection, Fungal Infection Lungs

In brief

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.

Key facts

Study ID

NCT07681583

Run by

Azienda Ospedaliero-Universitaria Careggi

People needed

400

Starts

2025-11-13

Expected to finish

2031-11-13

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Careggi University Hospital — Florence, Italy (enrolling)

Full record on ClinicalTrials.gov

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