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

Recruitingn/aAges 18 Years - 90 YearsAllAzienda Ospedaliero-Universitaria Careggi
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In plain words

What the trial is, and whether it could suit you

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 diag

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📋 Eligibility rules (as published)
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.
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What it tests

  • FUNGAL-P Score Assessment
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Where

1 site
Careggi University Hospital
Florence, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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