NCT07681583 Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
| NCT ID | NCT07681583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero-Universitaria Careggi |
| Condition | Pneumonia |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-11-13 |
| Primary Completion | 2030-11-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2025-11-13 with a primary completion date of 2030-11-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Lorenzo Pelagatti, MD, PhD
PRINCIPAL INVESTIGATOR
University of Florence
Frequently Asked Questions
Who can join the NCT07681583 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07681583 currently recruiting?
Yes, NCT07681583 is actively recruiting participants. Contact the research team at pelagattil@aou-careggi.toscana.it for enrollment information.
Where is the NCT07681583 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT07681583 clinical trial?
NCT07681583 is sponsored by Azienda Ospedaliero-Universitaria Careggi. The principal investigator is Lorenzo Pelagatti, MD, PhD at University of Florence. The trial plans to enroll 400 participants.