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Enrolling by invitation NCT07070284

ESCAPE10: Epidemiology, Risk Factors, and Outcomes of Severe Community-acquired Pneumonia in Elderly Patients Acquired Pneumonia in Elderly Patients

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Severe Community-Acquired Pneumonia (sCAP), Elderly Infection, Community-Acquired Infections, Health Care Quality, Access, and Evaluation. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Croatia, France, Greece, Italy, Portugal +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • 28-day All-Cause Mortality [Time frame: 28 days from admission]
Secondary outcome measures (8)
  • In-Hospital Mortality (All Cause) [Time frame: From hospital admission through hospital discharge (average of 5 to 30 days)]
  • Pneumonia-Attributed In-Hospital Mortality [Time frame: From hospital admission through hospital discharge (average of 5 to 30 days)]
  • Length of Hospital Stay (LOS) [Time frame: Through hospital discharge (average of 5 to 30 days)]
  • Duration of ICU Stay [Time frame: Through ICU or High Dependency Unit (HDU) discharge (average of 2 to 15 days)]
  • Duration of Mechanical Ventilation [Time frame: Through hospital discharge (average of 2 to 20 days)]
  • Rate of Pneumonia-Related Complications [Time frame: From hospital admission to hospital discharge, up to a maximum of 30 days]
  • Functional Status at Discharge [Time frame: At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course)]
  • Cognitive Function at Discharge [Time frame: At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 5 centers
  • Thibaut Fraisse — Alès
  • Centre Hospitalier Intercommunal Hôpitaux du Pays du Mont-Blanc - Site de Chamonix — Chamonix
  • Centre hospitalier Alpes Léman — Contamine-sur-Arve
  • Centre Hospitalier de Melun — Melun
  • Hôpital Bichat - Claude-Bernard — Paris
Italy · 5 centers
  • Azienda Ospedaliero-Universitaria di Modena — Modena
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I — Rome
  • ASST del Garda - Ospedale Civile "La Memoria" di Gavardo — Gavardo
  • ARNAS Civico-Di Cristina-Benfratelli Hospital - Infectious Diseases Unit — Palermo
  • Azienda Ospedaliero-Universitaria Pisana — Pisa
Spain · 5 centers
  • Hospital Universitario Virgen del Rocío — Seville
  • Bellvitge Universitary Hospital — L'Hospitalet de Llobregat
  • Hospital del Mar Barcelona — Barcelona
  • Corporació Sanitària Parc Taulí — Sabadell
  • Hospital Universitario Donostia — Donostia / San Sebastian
Croatia · 1 center
  • University Hospital for Infectious Diseases Dr. Fran Mihaljević — Zagreb
Greece · 1 center
  • Evangelismos General Hospital — Athens
Portugal · 1 center
  • Centro Hospitalar Universitário de São João (CHUSJ) — Porto

Identifiers

NCT: NCT07070284 · ESCAPE10 STUDY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗