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Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score (FUNGAL-P)

26 giugno 2026 aggiornato da: Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

400

Contatti e Sedi

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Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: 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.
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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score
Lasso di tempo: At completion of study analysis (30 days)
Evaluation of the discriminative ability of the FUNGAL-P score for identifying fungal pneumonia.
At completion of study analysis (30 days)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score
Lasso di tempo: At completion of study analysis (30 days)
Evaluation of the discriminative ability of the FUNGAL-P score for identifying fungal pneumonia.
At completion of study analysis (30 days)
Sensitivity and specificity of the FUNGAL-P score
Lasso di tempo: At completion of study analysis (30 days)
Assessment of sensitivity, specificity, positive predictive value, and negative predictive value of the FUNGAL-P score at predefined score thresholds.
At completion of study analysis (30 days)
Calibration of the FUNGAL-P score
Lasso di tempo: At completion of study analysis (30 days)
Assessment of agreement between predicted and observed probabilities of fungal pneumonia using calibration plots and the Hosmer-Lemeshow test.
At completion of study analysis (30 days)
Clinical utility of the FUNGAL-P score
Lasso di tempo: At completion of study analysis (30 days)
Evaluation of the net clinical benefit of the FUNGAL-P score using Decision Curve Analysis.
At completion of study analysis (30 days)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Investigatori

  • Investigatore principale: Lorenzo Pelagatti, MD, PhD, University of Florence

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

  • 1. Esandi M, Magnasco L, Farina EC, et al. Early diagnosis of candidiasis in non-neutropenic critically ill patients: prospective study. Intensive Care Med. 2003;29(9):1534-1540. doi:10.1007/s00134-003-1825-3 2. Wang K, Wang Y, Liu M, et al. Retrospective evaluation of risk factors for invasive Candida infections in a medical ICU. Medicine (Baltimore). 2024;103(14):e38338. doi:10.1097/MD.0000000000038338 3. Kullberg BJ, Arendrup MC. Invasive candidiasis. N Engl J Med. 2015;373(15):1445-1456. doi:10.1056/NEJMra1315399 4. Playford EG, Eggimann P, Calandra T, et al. Epidemiology of invasive candidiasis in non-neutropenic critically ill patients. Lancet Infect Dis. 2010;10(12):775-784. doi:10.1016/S1473-3099(10)70267-7 5. Leroy G, Lambiotte F, Thévenin D, et al. Risk factors of invasive fungal disease in critically ill adult patients: a systematic review. Crit Care. 2012;16(5):R242. doi:10.1186/cc11844 6. Aguilar C, Kumar D, Humar A, et al. Risk factors for invasive fungal infections in lung transplant recipients: a systematic review and meta-analysis. Clin Transplant. 2021;35(4):e14232. doi:10.1111/ctr.14232 7. Li Y, Wang J, Zhang H, et al. A novel scoring system to predict invasive candidiasis in immunocompetent critically ill patients. Front Microbiol. 2023;14:1097574. doi:10.3389/fmicb.2023.1097574 8. Bougnoux ME, Kac G, Aegerter P, et al. Candidemia and Candida colonization in critically ill patients: incidence and risk factors. Intensive Care Med. 2008;34(11):1955-1961. doi:10.1007/s00134-008-1197-4 9. Bassetti M, Righi E, Ansaldi F, et al. A multicenter study of candidemia in intensive care units in Italy. Intensive Care Med. 2006;32(10):1523-1529. doi:10.1007/s00134-006-0298-8 10. Blot SI, Taccone FS, Van den Abeele AM, et al. A clinical algorithm to diagnose invasive pulmonary aspergillosis in critically ill patients. Intensive Care Med. 2012;38(9):1294-1303. doi:10.1007/s00134-012-2600-5 11. Lu LY, Cheng Y, Wang H, et al. Risk factors and outcomes of influenza

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 novembre 2025

Completamento primario (Stimato)

13 novembre 2030

Completamento dello studio (Stimato)

13 novembre 2031

Date di iscrizione allo studio

Primo inviato

26 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CEAVC 29602

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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