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Enrolling by Invitation

NCT Number: NCT07070284

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital for Infectious Diseases Dr. Fran Mihaljević, Zagreb, City of Zagreb, Croatia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 28-day All-Cause Mortality

    Time frame: 28 days from admission

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

Secondary outcomes

  1. In-Hospital Mortality (All Cause)

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

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

  2. Pneumonia-Attributed In-Hospital Mortality

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

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

  3. Length of Hospital Stay (LOS)

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

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

  4. Duration of ICU Stay

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

    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.

  5. Duration of Mechanical Ventilation

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

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

  6. Rate of Pneumonia-Related Complications

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

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

  7. Functional Status at Discharge

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

    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)

  8. Cognitive Function at Discharge

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

    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)

Sponsors and collaborators

Lead sponsor

Joan Sabater-Riera

Other

Collaborators

  • European Society of Clinical Microbiology and Infectious Diseases
  • Hospital Universitari de Bellvitge

Registry information

Official study title

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

Acronym: ESCAPE10

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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