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

Sponsor
Azienda Ospedaliero-Universitaria Careggi
Study ID
NCT07681583
Status
Recruiting
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Conditions

  • Aspergillosis Pneumonia
  • Fungal Disease
  • Fungal Infection
  • Fungal Infection Lungs
  • Fungal Pneumonia
  • Pneumocystis
  • Pneumocystis Pneumonia
  • Pneumonia
  • Pulmonary Aspergillosis
  • Pulmonary Aspergillosis Invasive

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • FUNGAL-P Score Assessment — OTHER
    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 Details

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 Dates

First listed
Jul 2, 2026
Start date
Nov 13, 2025
Status verified
Jun 2026
Primary completion
Nov 13, 2030
Completion
Nov 13, 2031

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Retrospective Derivation Cohort
    Adult patients with microbiologically confirmed pneumonia enrolled at Careggi University Hospital between January 1, 2022 and December 31, 2023. Clinical, laboratory, radiological, microbiological, treatment, and outcome data were collected to identify independent predictors of fungal pneumonia and to derive the FUNGAL-P clinical prediction score.
  • Arm: Prospective Validation Cohort
    Consecutive adult patients with pneumonia enrolled at Careggi University Hospital between 13 nov, 2025 and December 31, 2030. The cohort was used to prospectively evaluate the diagnostic performance, calibration, and clinical utility of the derived FUNGAL-P score without influencing clinical management.

Primary Outcome Measure

Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score [ Time Frame: At completion of study analysis (30 days) ]

Central Contacts

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