NCT07070284

ESCAPE10: Epidemiology, Risk Factors, and Outcomes of Severe Community-acquired Pneumonia in Elderly PatientsAcquired Pneumonia (sCAP) in Elderly Patients"

"Escape 10 Study. Epidemiology and Determinants of Outcomes of Severe Community-acquired Pneumonia in the Elderly"

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Joan Sabater Riera · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Severe Community-Acquired Pneumonia (sCAP)
• Elderly Infection
• Community-Acquired Infections
• Health Care Quality, Access, and Evaluation

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2025-07-17
• Last updated: 2025-07-17

Locations

18 sites across 6 countries: Croatia, France, Greece, Italy, Portugal, Spain