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| Name | Class |
|---|---|
| European Society of Clinical Microbiology and Infectious Diseases | OTHER |
| Hospital Universitari de Bellvitge | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From hospital admission through hospital discharge (average of 5 to 30 days) |
| Pneumonia-Attributed In-Hospital Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jordi Rello, phD, MD | European Study Group Infections in the Elderly. ESCMID | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital for Infectious Diseases Dr. Fran Mihaljević | Zagreb | City of Zagreb | 10000 | Croatia | ||
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2025 |
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Proportion of participants whose death during hospitalization was determined to be directly attributable to pneumonia, based on physician documentation and medical record review |
| From hospital admission through hospital discharge (average of 5 to 30 days) |
| Length of Hospital Stay (LOS) | Duration of hospitalization, measured in calendar days from the date of admission to the date of discharge | Through hospital discharge (average of 5 to 30 days) |
| 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. | Through ICU or High Dependency Unit (HDU) discharge (average of 2 to 15 days) |
| Duration of Mechanical Ventilation | Total number of calendar days a participant receives invasive or non-invasive mechanical ventilation during hospitalization. | Through hospital discharge (average of 2 to 20 days) |
| Rate of Pneumonia-Related Complications | Incidence of complications such as ARDS, septic shock, bacteremia, empyema, or VAP | From hospital admission to hospital discharge, up to a maximum of 30 days |
| 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) | At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course) |
| 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) | At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course) |
| 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 |
| May 7, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D017714 | Community-Acquired Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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