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
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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ENROLLING_BY_INVITATION
500 participants
OBSERVATIONAL
2025-05-01
2025-11-30
Brief Summary
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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.
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Detailed Description
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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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Study Design
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COHORT
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 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
* 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.
65 Years
ALL
No
Sponsors
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European Society of Clinical Microbiology and Infectious Diseases
OTHER
Hospital Universitari de Bellvitge
OTHER
Joan Sabater Riera
OTHER
Responsible Party
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Joan Sabater Riera
Head of the Medical Unit, Department of Critical Care
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
Thibaut Fraisse
Alès, , France
Centre Hospitalier Intercommunal Hôpitaux du Pays du Mont-Blanc - Site de Chamonix
Chamonix, , France
Centre hospitalier Alpes Léman
Contamine-sur-Arve, , France
Centre Hospitalier de Melun
Melun, , France
Hôpital Bichat - Claude-Bernard
Paris, , France
Evangelismos General Hospital
Athens, , Greece
Azienda Ospedaliero-Universitaria di Modena
Modena, Emilia-Romagna, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, Lazio, Italy
ASST del Garda - Ospedale Civile "La Memoria" di Gavardo
Gavardo, Lombardy, Italy
ARNAS Civico-Di Cristina-Benfratelli Hospital - Infectious Diseases Unit
Palermo, Sicily, Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, Tuscany, Italy
Centro Hospitalar Universitário de São João (CHUSJ)
Porto, , Portugal
Hospital Universitario Virgen del Rocío
Seville, Andalusia, Spain
Bellvitge Universitary Hospital
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital del Mar Barcelona
Barcelona, Catalonia, Spain
Corporació Sanitària Parc Taulí
Sabadell, Catalunuya, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ESCAPE10 STUDY
Identifier Type: -
Identifier Source: org_study_id
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