FUNGAL-P Score Assessment: Observational 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score — At completion of study analysis (30 days) Evaluation of the discriminative ability of the FUNGAL-P score for identifying fungal pneumonia.
Trial sites (1)
Facility
City
Region
Status
Careggi University Hospital
Florence
Italy
Recruiting
More Azienda Ospedaliero-Universitaria Careggi trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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