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

NCT ID: NCT07070284

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-11-30

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society of Clinical Microbiology and Infectious Diseases

OTHER

Sponsor Role collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role collaborator

Joan Sabater Riera

OTHER

Sponsor Role lead

Responsible Party

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Joan Sabater Riera

Head of the Medical Unit, Department of Critical Care

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jordi Rello, phD, MD

Role: PRINCIPAL_INVESTIGATOR

European Study Group Infections in the Elderly. ESCMID

Locations

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University Hospital for Infectious Diseases Dr. Fran Mihaljević

Zagreb, City of Zagreb, Croatia

Site Status

Thibaut Fraisse

Alès, , France

Site Status

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

Chamonix, , France

Site Status

Centre hospitalier Alpes Léman

Contamine-sur-Arve, , France

Site Status

Centre Hospitalier de Melun

Melun, , France

Site Status

Hôpital Bichat - Claude-Bernard

Paris, , France

Site Status

Evangelismos General Hospital

Athens, , Greece

Site Status

Azienda Ospedaliero-Universitaria di Modena

Modena, Emilia-Romagna, Italy

Site Status

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Rome, Lazio, Italy

Site Status

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

Gavardo, Lombardy, Italy

Site Status

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

Palermo, Sicily, Italy

Site Status

Azienda Ospedaliero-Universitaria Pisana

Pisa, Tuscany, Italy

Site Status

Centro Hospitalar Universitário de São João (CHUSJ)

Porto, , Portugal

Site Status

Hospital Universitario Virgen del Rocío

Seville, Andalusia, Spain

Site Status

Bellvitge Universitary Hospital

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital del Mar Barcelona

Barcelona, Catalonia, Spain

Site Status

Corporació Sanitària Parc Taulí

Sabadell, Catalunuya, Spain

Site Status

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, Spain

Site Status

Countries

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Croatia France Greece Italy Portugal Spain

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ESCAPE10 STUDY

Identifier Type: -

Identifier Source: org_study_id

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