Escape 10 Study: Epidemiology and Determinants of Outcomes of Severe Community-acquired Pneumonia in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 18
- 主要终点
- 28-day All-Cause Mortality
研究概览
简要总结
The ESCAPE 10 study is a multinational, retrospective, observational cohort study that aims to investigate the epidemiology and outcome determinants of severe community-acquired pneumonia (sCAP) in elderly patients (≥65 years). Conducted across multiple European countries, the study will include at least 500 patients admitted to acute care hospitals with radiologically confirmed sCAP, with enrollment distributed evenly between epidemic (winter) and non-epidemic (summer) seasons.
The primary objective is to assess 28-day mortality. Secondary objectives include evaluating in-hospital mortality, pneumonia-related complications, Intensive Care Unit (ICU) stay, ventilation needs, and identifying clinical risk factors associated with poor outcomes. Additionally, the study aims to propose a set of quality indicators for sCAP management and assess gender-related differences and clinical subphenotypes in the post-COVID-19 era.
Data will be retrospectively collected from medical records, with no interventions applied. Findings from this study are expected to guide improvements in clinical care, patient safety, and outcome prediction models in elderly populations with sCAP.
详细描述
Severe community-acquired pneumonia (sCAP) remains a leading cause of morbidity and mortality in older adults, especially those aged 65 years and above. The ESCAPE 10 study is a multinational, retrospective, observational cohort study designed to explore the epidemiological patterns, clinical characteristics, and outcomes of elderly patients hospitalized with sCAP across diverse European settings.
The study will include at least 500 patients enrolled over a 13-month period (January 1, 2024, to January 31, 2025), with data collection evenly split between epidemic (winter influenza) and non-epidemic (summer) seasons. Participating centers will retrospectively identify eligible patients using standardized inclusion criteria: age ≥65, radiologically confirmed pneumonia, and fulfillment of protocol-defined sCAP criteria. Patients with recent hospitalization, terminal illness, or under palliative care will be excluded.
The primary outcome is 28-day all-cause mortality. Secondary outcomes include in-hospital mortality, pneumonia-attributed mortality, length of hospital and ICU stay, rate of complications (such as Acute Respiratory Distress Syndrome (ARDS), Ventilator-Associated Pneumonia (VAP), septic shock), functional and cognitive status at discharge, and identification of risk factors for adverse outcomes. Quality of care will be assessed through predefined indicators including timeliness of antibiotic administration, adherence to clinical guidelines, and preventive measures like vaccination status.
This study also aims to assess gender differences in sCAP presentation and outcomes, define clinical endotypes, and develop a framework of quality indicators for elderly care in sCAP. No patient interventions will be performed, and data will be extracted from medical records using a secure, coded system Research Electronic Data Capture (REDCap). The results will inform clinical decision-making and quality improvement efforts in the management of sCAP in elderly patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years-old or older.
- •Patients with clinically and radiologically (Chest X-Ray (CXR), Computerized Tomography (CT) or lung ultrasound (LUS) confirmed pneumonia.
- •Patients fulfilling the protocol definition of sCAP
排除标准
- •Age < 65 years.
- •Recent hospitalization (above 48 h within the past 10 days) in acute healthcare settings.
- •Terminal events or imminent death
- •Patients receiving comfort care only or with documented decisions to forgo intensive medical interventions.
研究组 & 干预措施
Severe Community-Acquired Pneumonia in the Elderly
Participants aged 65 years or older who were hospitalized with radiologically confirmed severe community-acquired pneumonia (sCAP), as defined by protocol criteria. All patients included met clinical and radiological criteria for sCAP and were admitted to an acute care hospital during the defined inclusion period.
结局指标
主要结局
28-day All-Cause Mortality
时间窗: 28 days from admission
Number of participants who die from any cause within 28 days from the date of hospital admission.
次要结局
- In-Hospital Mortality (All Cause)(From hospital admission through hospital discharge (average of 5 to 30 days))
- Pneumonia-Attributed In-Hospital Mortality(From hospital admission through hospital discharge (average of 5 to 30 days))
- Length of Hospital Stay (LOS)(Through hospital discharge (average of 5 to 30 days))
- Duration of ICU Stay(Through ICU or High Dependency Unit (HDU) discharge (average of 2 to 15 days))
- Duration of Mechanical Ventilation(Through hospital discharge (average of 2 to 20 days))
- Rate of Pneumonia-Related Complications(From hospital admission to hospital discharge, up to a maximum of 30 days)
- Functional Status at Discharge(At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course))
- Cognitive Function at Discharge(At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course))
研究者
Joan Sabater-Riera
Head of the Medical Unit, Department of Critical Care
Hospital Universitari de Bellvitge