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

J

Joan Sabater Riera

Status

Invitation-only

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT07070284
ESCAPE10 STUDY

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Trial design

500 participants in 1 patient group

Severe Community-Acquired Pneumonia in the Elderly
Description:
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.

Trial documents
1

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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