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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Careggi University Hospital
RECRUITING
Florence
Contact Information
Primary
Lorenzo Pelagatti, MD, PhDs
pelagattil@aou-careggi.toscana.it
+39 3385917317
Backup
Peiman Nazerian, MD
nazierianp@aou-careggi.toscana.it
Time Frame
Start Date: 2025-11-13
Estimated Completion Date: 2031-11-13
Participants
Target number of participants: 400
Treatments
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.
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.
Sponsors
Leads: Azienda Ospedaliero-Universitaria Careggi

This content was sourced from clinicaltrials.gov

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