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

NCT07070284 | Enrolling By Invitation

• 1 other identifier: ESCAPE10 STUDY
• Study Type: observational
• Target: 500
• Locations: 6 countries
• Sites: 18

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 28-day All-Cause Mortality

  Number of participants who die from any cause within 28 days from the date of hospital admission.

  28 days from admission

Secondary Outcomes (8)

• 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)

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients aged 65 years or older with a clinical and radiological diagnosis of severe community-acquired pneumonia (sCAP). Participants will be enrolled retrospectively from multiple European centers, representing a diverse elderly population. The study includes patients admitted during both epidemic (winter) and non-epidemic (summer) seasons to capture seasonal variations in pathogen distribution and clinical outcomes.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joan Sabater Riera: lead
• European Society of Clinical Microbiology and Infectious Diseases: collaborator
• Hospital Universitari de Bellvitge: collaborator

Study Sites (18)

University Hospital for Infectious Diseases Dr. Fran Mihaljević

Zagreb, City of Zagreb, 10000, Croatia

Location

Thibaut Fraisse

Alès, 30103, France

Location

Centre Hospitalier Intercommunal Hôpitaux du Pays du Mont-Blanc - Site de Chamonix

Chamonix, 74400, France

Location

Centre hospitalier Alpes Léman

Contamine-sur-Arve, 74130, France

Location

Centre Hospitalier de Melun

Melun, 77000, France

Location

Hôpital Bichat - Claude-Bernard

Paris, 75018, France

Location

Evangelismos General Hospital

Athens, 10676, Greece

Location

Azienda Ospedaliero-Universitaria di Modena

Modena, Emilia-Romagna, 41124, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Rome, Lazio, 00161, Italy

Location

ASST del Garda - Ospedale Civile "La Memoria" di Gavardo

Gavardo, Lombardy, 25085, Italy

Location

ARNAS Civico-Di Cristina-Benfratelli Hospital - Infectious Diseases Unit

Palermo, Sicily, 90127, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, Tuscany, 56126, Italy

Location

Centro Hospitalar Universitário de São João (CHUSJ)

Porto, 4200-319, Portugal

Location

Hospital Universitario Virgen del Rocío

Seville, Andalusia, 41013, Spain

Location

Bellvitge Universitary Hospital

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital del Mar Barcelona

Barcelona, Catalonia, 08003, Spain

Location

Corporació Sanitària Parc Taulí

Sabadell, Catalunuya, 08208, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Community-Acquired Infections

Condition Hierarchy (Ancestors)

Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Jordi Rello, phD, MD

  European Study Group Infections in the Elderly. ESCMID

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Medical Unit, Department of Critical Care

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: July 17, 2025
• Study Start: May 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5); ES (5); FR (5); GR (1); CR (1); PT (1)