Derivation and Validation of the Risk Evaluation Score for Pneumonia Involving Resistant Entities (RESPIRE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Clinical score (RESPIRE) derivation
研究概览
简要总结
This is a single-center, non-profit observational study with two sequential phases: an initial retrospective phase followed by a prospective phase. Patients were enrolled during two consecutive, non-overlapping periods.
The primary objective of the study is to derive a clinical predictive score for multidrug-resistant (MDR) pathogen-related pneumonia in patients diagnosed with pneumonia presenting to the Emergency Department and/or admitted to the hospital from the community.
详细描述
Study Design and Setting
This is a single-center, non-profit observational study with two sequential phases: an initial retrospective phase and a subsequent prospective phase. Patients were enrolled during two consecutive, non-overlapping periods: from January 1, 2022 to December 31, 2023 (retrospective cohort), and from January 1, 2024 to December 31, 2025 (prospective cohort).
The study was conducted in a hospital setting and is monocentric, carried out at the Emergency Department and the Emergency Sub-Intensive Care Unit of Azienda Ospedaliero Universitaria Careggi, in collaboration with the Units of Microbiology and Virology and Infectious Diseases. Careggi is a large academic hospital that serves as the local hospital for a population of approximately 650,000 inhabitants and acts as a tertiary referral center for about 1,600,000 people.
Retrospective Phase (Derivation Cohort)
During the first observational retrospective phase (2 years), data were collected to establish a retrospective derivation cohort composed of patients with microbiologically confirmed etiological diagnoses of pneumonia. The derivation cohort includes patients who underwent microbiological investigations aimed at identifying the etiological diagnosis of pneumonia within the first 48 hours from admission to Azienda Ospedaliero Universitaria Careggi.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •All patients:
- •aged ≥18 years
- •who underwent respiratory sample collection within 48 hours of hospital admission and had subsequent positive culture results oleading to a confirmed etiological diagnosis of community-acquired pneumonia (CAP)
- •Pneumonia was clinically defined by the presence of two or more clinical signs or symptoms (body temperature <36.0°C or >38.0°C; respiratory rate >20 breaths/min; oxygen saturation on room air <90%; arterial partial pressure of oxygen <60 mmHg; cough; sputum production; white blood cell count <4,000/μL or >10,000/μL; bandemia >10%), in addition to radiographic evidence of a new parenchymal opacity or cavitation.
- •Only patients with positive respiratory culture results were included in the analysis.
- •During the prospective phase, only patients whose microbiological samples were collected in the Emergency Department were enrolled.
排除标准
- •informed consent was not provided
- •age was <18 years or >90 years
- •pneumonia occurred after more than 48 hours from hospital admission (hospital-acquired pneumonia).
研究组 & 干预措施
MDR Pneumonia Group (Derivation Cohort)
Patients with microbiologically confirmed bacterial pneumonia caused by multidrug-resistant (MDR) pathogens, identified on respiratory culture and antimicrobial susceptibility testing, enrolled during the retrospective phase. MDR was defined as acquired non-susceptibility to at least one agent in three or more antimicrobial categories.
干预措施: RESPIRE score (Other)
Non-MDR Pneumonia Group (Derivation Cohort)
Patients with microbiologically confirmed bacterial pneumonia caused by non-multidrug-resistant pathogens, identified on respiratory culture with available antimicrobial susceptibility testing, enrolled during the retrospective phase. This group served as the comparison cohort for score derivation.
干预措施: RESPIRE score (Other)
Pneumonia Validation Cohort (Prospective)
Consecutive patients presenting to the Emergency Department with a diagnosis of pneumonia who underwent microbiological investigations on respiratory samples during the prospective phase (January 1, 2024-December 31, 2025). This cohort was used to prospectively validate the clinical predictive score derived from the retrospective cohort in a purely observational manner.
干预措施: RESPIRE score (Other)
结局指标
主要结局
Clinical score (RESPIRE) derivation
时间窗: Within 48 hours from Emergency Department presentation / hospital admission.
The primary objective of the study is to derive a clinical predictive score for MDR pathogen-related pneumonia in patients diagnosed with pneumonia presenting to the Emergency Department and/or admitted to the hospital from the community.
次要结局
- validation of the derived clinical score in a prospective patient cohort;(Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.)
- comparison of the performance of the developed score in predicting MDR-related pneumonia with validated scores(Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.)
- PPV, NPV, specificity, sensitivity, LR+, LR-, Youden(Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.)
- Calibration(Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.)
- Clinical utiliy(Within 48 hours of the index Emergency Department presentation or hospital admission for pneumonia.)
研究者
Peiman Nazerian
Dr
Azienda Ospedaliero-Universitaria Careggi