Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
NCT07681583 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400
Last updated 2026-07-02
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.
Conditions
- Pneumonia
- Fungal Pneumonia
- Aspergillosis Pneumonia
- Pulmonary Aspergillosis
- Pulmonary Aspergillosis Invasive
- Pneumocystis
- Pneumocystis Pneumonia
- Fungal Disease
- Fungal Infection
- Fungal Infection Lungs
Interventions
- OTHER
-
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.
Sponsors & Collaborators
-
Azienda Ospedaliero-Universitaria Careggi
lead OTHER
Principal Investigators
-
Lorenzo Pelagatti, MD, PhD · University of Florence
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-13
- Primary Completion
- 2030-11-13
- Completion
- 2031-11-13
Countries
- Italy
Study Locations
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