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Enrolling by invitationNCT07070284ESCAPE10Updated May 15, 2026

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

An observational study in Severe Community-Acquired Pneumonia (sCAP), Elderly Infection and Community-Acquired Infections, sponsored by Joan Sabater-Riera. Enrolling by invitation at 18 sites in 6 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Joan Sabater-Riera · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Severe Community-Acquired Pneumonia (sCAP)
  • Elderly Infection
  • Community-Acquired Infections
  • Health Care Quality, Access, and Evaluation
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

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.

    Time frame: 28 days from admission

Secondary outcomes

  1. In-Hospital Mortality (All Cause)

    Proportion of participants who die from any cause during their hospital stay, from admission to discharge, regardless of length of stay.

    Time frame: From hospital admission through hospital discharge (average of 5 to 30 days)

  2. Pneumonia-Attributed In-Hospital Mortality

    Proportion of participants whose death during hospitalization was determined to be directly attributable to pneumonia, based on physician documentation and medical record review

    Time frame: From hospital admission through hospital discharge (average of 5 to 30 days)

  3. Length of Hospital Stay (LOS)

    Duration of hospitalization, measured in calendar days from the date of admission to the date of discharge

    Time frame: Through hospital discharge (average of 5 to 30 days)

  4. Duration of ICU Stay

    Number of calendar days each participant spends in an Intensive Care Unit (ICU) or High-Dependency Unit (HDU), from ICU/HDU admission to ICU/HDU discharge.

    Time frame: Through ICU or High Dependency Unit (HDU) discharge (average of 2 to 15 days)

  5. Duration of Mechanical Ventilation

    Total number of calendar days a participant receives invasive or non-invasive mechanical ventilation during hospitalization.

    Time frame: Through hospital discharge (average of 2 to 20 days)

  6. Rate of Pneumonia-Related Complications

    Incidence of complications such as ARDS, septic shock, bacteremia, empyema, or VAP

    Time frame: From hospital admission to hospital discharge, up to a maximum of 30 days

  7. Functional Status at Discharge

    Assessment of the patient's physical functional level at the time of hospital discharge, using standardized scales such as the Barthel Index or Clinical Frailty Scale, when available. The chosen scale will be specified in each case. Units of Measure: Score on a standardized functional scale (e.g., Barthel Index, 0-100, where higher scores indicate better function; or Clinical Frailty Scale, 1-9, where higher scores indicate worse function)

    Time frame: At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course)

  8. Cognitive Function at Discharge

    Evaluation of cognitive status at the time of hospital discharge using available documentation from the medical record and/or validated tools such as the Confusion Assessment Method (CAM) or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) when available. Presence or absence of delirium and/or cognitive decline will be recorded. Units of Measure: Cognitive function status (e.g., presence or absence of delirium based on CAM or CAM-ICU; categorical assessment)

    Time frame: At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course)

06

Study locations

18 sites
  • University Hospital for Infectious Diseases Dr. Fran Mihaljević
    Zagreb, City of Zagreb 10000, Croatia
  • Thibaut Fraisse
    Alès, 30103, France
  • Centre Hospitalier Intercommunal Hôpitaux du Pays du Mont-Blanc - Site de Chamonix
    Chamonix, 74400, France
  • Centre hospitalier Alpes Léman
    Contamine-sur-Arve, 74130, France
  • Centre Hospitalier de Melun
    Melun, 77000, France
  • Hôpital Bichat - Claude-Bernard
    Paris, 75018, France
  • Evangelismos General Hospital
    Athens, 10676, Greece
  • Azienda Ospedaliero-Universitaria di Modena
    Modena, Emilia-Romagna 41124, Italy
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I
    Rome, Lazio 00161, Italy
  • ASST del Garda - Ospedale Civile "La Memoria" di Gavardo
    Gavardo, Lombardy 25085, Italy
  • ARNAS Civico-Di Cristina-Benfratelli Hospital - Infectious Diseases Unit
    Palermo, Sicily 90127, Italy
  • Azienda Ospedaliero-Universitaria Pisana
    Pisa, Tuscany 56126, Italy
  • Centro Hospitalar Universitário de São João (CHUSJ)
    Porto, 4200-319, Portugal
  • Hospital Universitario Virgen del Rocío
    Seville, Andalusia 41013, Spain
  • Bellvitge Universitary Hospital
    L'Hospitalet de Llobregat, Barcelona 08907, Spain
  • Hospital del Mar Barcelona
    Barcelona, Catalonia 08003, Spain
  • Corporació Sanitària Parc Taulí
    Sabadell, Catalunuya 08208, Spain
  • Hospital Universitario Donostia
    Donostia / San Sebastian, Gipuzkoa 20014, Spain
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 1, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07070284
Lead sponsor
Joan Sabater-Riera
Collaborators
European Society of Clinical Microbiology and Infectious Diseases, Hospital Universitari de Bellvitge
Responsible party
Joan Sabater-Riera (Head of the Medical Unit, Department of Critical Care, Hospital Universitari de Bellvitge) — Sponsor-investigator
First posted
Jul 17, 2025
Start date
May 1, 2025
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
May 15, 2026

Study contacts

Jordi Rello, phD, MD
principal investigator · European Study Group Infections in the Elderly. ESCMID

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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