An observational study in Pneumonia, Fungal Pneumonia and Aspergillosis Pneumonia, sponsored by Azienda Ospedaliero-Universitaria Careggi. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Azienda Ospedaliero-Universitaria Careggi · Observational
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.
Fungal pneumonia is an increasingly recognized cause of severe respiratory infection and is associated with substantial morbidity and mortality. Early diagnosis remains challenging because clinical manifestations are often nonspecific and conventional diagnostic criteria may not be readily applicable in emergency care settings. Delayed recognition may result in delayed diagnostic investigations and initiation of targeted antifungal therapy.
The FUNGAL-P study is a no-profit, single-center observational study conducted at Careggi University Hospital (Florence, Italy). The study was designed to derive and validate a clinical prediction rule for the early identification of fungal pneumonia or fungal-bacterial coinfection among adult patients presenting with pneumonia.
The study consists of two sequential phases.
Retrospective derivation phase
The derivation cohort includes adult patients with microbiologically confirmed pneumonia diagnosed between January 1, 2022 and December 31, 2023. Eligible patients underwent bronchoalveolar lavage (BAL), bronchial aspirate, or endotracheal aspirate collection within 48 hours of hospital presentation. Microbiological investigations included fungal and bacterial cultures, galactomannan testing, molecular assays for Aspergillus species and Pneumocystis jirovecii, and multiplex molecular respiratory pathogen testing.
Patients with microbiologically confirmed fungal pneumonia constituted the study group, whereas patients with bacterial or viral pneumonia served as controls. Cases of fungal-bacterial coinfection were classified as fungal pneumonia. Patients without microbiological identification of a pathogen were excluded.
Prospective validation phase
The validation cohort includes consecutive adult patients with pneumonia enrolled between January 1, 2024 and December 31, 2024. Patients underwent routine microbiological investigations according to standard clinical practice. The performance of the derived FUNGAL-P score was evaluated prospectively without influencing clinical decision-making.
Outcome definition
The primary study outcome is fungal pneumonia, including infections caused by Aspergillus species, Pneumocystis jirovecii, and other fungal pathogens, as well as fungal-bacterial coinfections. Diagnosis is based on an integrated assessment of clinical presentation, radiological findings, microbiological results, fungal biomarkers, and molecular testing results. Final case adjudication includes review of clinical follow-up data, imaging studies, microbiological findings, and treatment decisions.
Data collection
Demographic characteristics, medical history, comorbidities, fungal infection risk factors, vital signs, laboratory findings, radiological data, microbiological results, administered treatments, and clinical outcomes are collected for all participants.
Statistical analysis
Independent predictors of fungal pneumonia are identified using multivariable logistic regression. Candidate variables are selected based on prior evidence and univariable analyses. Predictors retained in the final model are incorporated into the FUNGAL-P score. Diagnostic performance is evaluated using sensitivity, specificity, predictive values, likelihood ratios, receiver operating characteristic (ROC) curves, and area under the ROC curve (AUROC). Calibration is assessed using calibration plots and the Hosmer-Lemeshow test. Internal validation is performed using bootstrap resampling, and clinical utility is evaluated through decision curve analysis.
Primary Objective
To derive a clinical prediction score for fungal pneumonia or fungal-bacterial coinfection in adult patients presenting with pneumonia.
Secondary Objectives
To prospectively validate the FUNGAL-P score. To assess score calibration and discrimination. To determine sensitivity, specificity, positive predictive value, and negative predictive value.
To evaluate the clinical utility of the score for identifying patients at increased risk of fungal pneumonia.
108 studies on the registry are indexed under Pneumonia, Pneumocystis; 16 are open to participants now.
This study's planned enrollment of 400 is above the median of 250 across 29 observational studies indexed under Pneumonia, Pneumocystis.
Browse Pneumonia, Pneumocystis studies →Azienda Ospedaliero-Universitaria Careggi is the lead sponsor of 77 studies on the registry; 23 are open to participants now.
Compared within Pneumonia, Pneumocystis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pneumonia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: FUNGAL-P Score Assessment
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.
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.
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.
Time frame: At completion of study analysis (30 days)
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.
Time frame: At completion of study analysis (30 days)
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.
Time frame: At completion of study analysis (30 days)
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.
Time frame: At completion of study analysis (30 days)
Clinical utility of the FUNGAL-P score
Evaluation of the net clinical benefit of the FUNGAL-P score using Decision Curve Analysis.
Time frame: At completion of study analysis (30 days)
Plan to share: Undecided
Started Nov 2025 (actual). Primary completion is estimated for Nov 2030, 60 months after the start.
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Azienda Ospedaliero-Universitaria Careggi