FUNGAL-P: A score to spot fungal pneumonia early in adults with pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The FUNGAL-P study is a two-phase, single-center observational investigation at Careggi University Hospital in Florence. It first derives a clinical prediction score from retrospective data, using clinical, lab, imaging, and microbiology results from adults with microbiologically evaluated lower respiratory samples. It then prospectively validates the score to assess diagnostic performance, calibration, and clinical usefulness in guiding testing and treatment decisions for suspected fungal pneumonia in the emergency department or hospital setting. The study addresses the challenge of early fungal pneumonia recognition due to nonspecific symptoms and aims to reduce delays in targeted antifungal therapy. It is conducted as a no-profit project focusing on deriving a practical tool for early identification and management.

Why it matters

Who can join: the full rules

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.

Where it's running

• Careggi University Hospital
  Florence, Italy Recruiting

Study contacts

• Principal investigator: Lorenzo Pelagatti, MD, PhD — University of Florence
• Study coordinator: Lorenzo Pelagatti, MD, PhDs
• Email: pelagattil@aou-careggi.toscana.it
• Phone: +39 3385917317

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.