Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <
- •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.
排除标准
- •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 ≥
- •Absence of microbiological diagnostic evaluation.
- •No identified bacterial, fungal, or viral pathogen after microbiological investigations.
结局指标
主要结局
Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score
时间窗: At completion of study analysis (30 days)
Evaluation of the discriminative ability of the FUNGAL-P score for identifying fungal pneumonia.
次要结局
- Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score(At completion of study analysis (30 days))
- Sensitivity and specificity of the FUNGAL-P score(At completion of study analysis (30 days))
- Calibration of the FUNGAL-P score(At completion of study analysis (30 days))
- Clinical utility of the FUNGAL-P score(At completion of study analysis (30 days))
研究者
Peiman Nazerian
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Azienda Ospedaliero-Universitaria Careggi