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.
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.
Refusal or withdrawal of informed consent.
Age <18 years or >90 years.
Pregnancy.
Expected life expectancy <3 months.
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.
Cohort
Other
FUNGAL-P Score Assessment
Other interventionObservational assessment of clinical, laboratory, radiological, and microbiological variables used to derive and validate the FUNGAL-P clinical prediction score for fungal pneumonia. No study-specific intervention was performed and patient management was not influenced by the study.
Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score
Evaluation of the discriminative ability of the FUNGAL-P score for identifying fungal pneumonia.
Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score
Evaluation of the discriminative ability of the FUNGAL-P score for identifying fungal pneumonia.
Sensitivity and specificity of the FUNGAL-P score
Assessment of sensitivity, specificity, positive predictive value, and negative predictive value of the FUNGAL-P score at predefined score thresholds.
Calibration of the FUNGAL-P score
Assessment of agreement between predicted and observed probabilities of fungal pneumonia using calibration plots and the Hosmer-Lemeshow test.
Clinical utility of the FUNGAL-P score
Evaluation of the net clinical benefit of the FUNGAL-P score using Decision Curve Analysis.
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