PneumoniaFUNGAL-PNCT07681583
Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
An observational study of Pneumonia and Fungal Pneumonia, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pneumonia, Fungal Pneumonia, Aspergillosis Pneumonia
- What is being tested?
- FUNGAL-P Score Assessment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 13 Nov 2025to 13 Nov 2031
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peiman Nazerian, MD contact
Italy1 site, 1 recruiting
- Recruiting
Careggi University Hospital
Florence
Lorenzo Pelagatti, MD, PhDs, +393385917317, pelagattil@aou-careggi.toscana.it
About this study
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.
Read the detailed description
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.
- Conditions
- Pneumonia, Fungal Pneumonia, Aspergillosis Pneumonia, Pulmonary Aspergillosis, Pulmonary Aspergillosis Invasive, Pneumocystis
- Being tested
- FUNGAL-P Score Assessment
- Keywords
- Fungal Pneumonia, Aspergillus, Pulmonary Aspergillosis, Pneumocystis jirovecii, Pneumocystis Pneumonia, Coinfection, Community-Acquired Pneumonia, CAP, Risk Prediction, Clinical Prediction Rule, Clinical Risk Score, FUNGAL-P Score, SCORE, Bronchoalveolar Lavage, Emergency Department, Internal medicine, Infectious disease, Diagnostic Accuracy, Risk Factors, Respiratory Infection
- Medical subject headings
- Pneumonia, Pulmonary Aspergillosis, Invasive Pulmonary Aspergillosis, Pneumonia, Pneumocystis, Mycoses, Coinfection, Community-Acquired Pneumonia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FUNGAL-P Score AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: FUNGAL-P Score Assessment | |
| 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. Receives: Other: FUNGAL-P Score Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score
Evaluation of the discriminative ability of the FUNGAL-P score for identifying fungal pneumonia.
Measured: At completion of study analysis (30 days)
Secondary outcomes (4)
Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score
Evaluation of the discriminative ability of the FUNGAL-P score for identifying fungal pneumonia.
Measured: At completion of study analysis (30 days)
Sensitivity and specificity of the FUNGAL-P score
Assessment of sensitivity, specificity, positive predictive value, and negative predictive value of the FUNGAL-P score at predefined score thresholds.
Measured: At completion of study analysis (30 days)
Calibration of the FUNGAL-P score
Assessment of agreement between predicted and observed probabilities of fungal pneumonia using calibration plots and the Hosmer-Lemeshow test.
Measured: At completion of study analysis (30 days)
Clinical utility of the FUNGAL-P score
Evaluation of the net clinical benefit of the FUNGAL-P score using Decision Curve Analysis.
Measured: At completion of study analysis (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start13 Nov 2025
- Primary completion13 Nov 2030 (estimated)
- Study completion13 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Lorenzo Pelagatti, MD, PhD, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681583
- Sponsor's protocol ID
- CEAVC 29602
- Acronym
- FUNGAL-P
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
- ClinicalTrials.gov ID
- NCT07681583
- Acronym / sponsor ID
- FUNGAL-P / CEAVC 29602
- Conditions
- Pneumonia, Fungal Pneumonia, Aspergillosis Pneumonia, Pulmonary Aspergillosis, Pulmonary Aspergillosis Invasive, Pneumocystis
- Keywords
- Fungal Pneumonia, Aspergillus, Pulmonary Aspergillosis, Pneumocystis jirovecii, Pneumocystis Pneumonia, Coinfection, Community-Acquired Pneumonia, CAP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 13 Nov 2030 (estimated)
- Study completion
- 13 Nov 2031 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Derivation Cohort | – | Other: FUNGAL-P Score AssessmentAdult 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 | – | Other: FUNGAL-P Score AssessmentConsecutive 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FUNGAL-P Score AssessmentObservational 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. | Other | Prospective Validation Cohort, Retrospective Derivation Cohort |
Primary outcome
Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score
Time frame: At completion of study analysis (30 days)
Evaluation of the discriminative ability of the FUNGAL-P score for identifying fungal pneumonia.
4 secondary outcomes
Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score
Time frame: At completion of study analysis (30 days)
Sensitivity and specificity of the FUNGAL-P score
Time frame: At completion of study analysis (30 days)
Calibration of the FUNGAL-P score
Time frame: At completion of study analysis (30 days)
Clinical utility of the FUNGAL-P score
Time frame: At completion of study analysis (30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background1. 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peiman Nazerian, MD contact
Lorenzo Pelagatti, MD, PhD principal investigator
University of Florence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Fungal Pneumonia, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Pelagatti, MD, PhDs (+39 3385917317, pelagattil@aou-careggi.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score (time frame: At completion of study analysis (30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07681583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.