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Набор по приглашению NCT07070284

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Severe Community-Acquired Pneumonia (sCAP), Elderly Infection, Community-Acquired Infections, Health Care Quality, Access, and Evaluation. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Хорватия, Франция, Греция, Италия, Португалия +1
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • 28-day All-Cause Mortality [Срок оценки: 28 days from admission]
Вторичные конечные точки (8)
  • In-Hospital Mortality (All Cause) [Срок оценки: From hospital admission through hospital discharge (average of 5 to 30 days)]
  • Pneumonia-Attributed In-Hospital Mortality [Срок оценки: From hospital admission through hospital discharge (average of 5 to 30 days)]
  • Length of Hospital Stay (LOS) [Срок оценки: Through hospital discharge (average of 5 to 30 days)]
  • Duration of ICU Stay [Срок оценки: Through ICU or High Dependency Unit (HDU) discharge (average of 2 to 15 days)]
  • Duration of Mechanical Ventilation [Срок оценки: Through hospital discharge (average of 2 to 20 days)]
  • Rate of Pneumonia-Related Complications [Срок оценки: From hospital admission to hospital discharge, up to a maximum of 30 days]
  • Functional Status at Discharge [Срок оценки: At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course)]
  • Cognitive Function at Discharge [Срок оценки: At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 5 центров
  • Thibaut Fraisse — Alès
  • Centre Hospitalier Intercommunal Hôpitaux du Pays du Mont-Blanc - Site de Chamonix — Chamonix
  • Centre hospitalier Alpes Léman — Contamine-sur-Arve
  • Centre Hospitalier de Melun — Melun
  • Hôpital Bichat - Claude-Bernard — Paris
Италия · 5 центров
  • Azienda Ospedaliero-Universitaria di Modena — Modena
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I — Rome
  • ASST del Garda - Ospedale Civile "La Memoria" di Gavardo — Gavardo
  • ARNAS Civico-Di Cristina-Benfratelli Hospital - Infectious Diseases Unit — Palermo
  • Azienda Ospedaliero-Universitaria Pisana — Pisa
Испания · 5 центров
  • Hospital Universitario Virgen del Rocío — Seville
  • Bellvitge Universitary Hospital — L'Hospitalet de Llobregat
  • Hospital del Mar Barcelona — Barcelona
  • Corporació Sanitària Parc Taulí — Sabadell
  • Hospital Universitario Donostia — Donostia / San Sebastian
Хорватия · 1 центр
  • University Hospital for Infectious Diseases Dr. Fran Mihaljević — Zagreb
Греция · 1 центр
  • Evangelismos General Hospital — Athens
Португалия · 1 центр
  • Centro Hospitalar Universitário de São João (CHUSJ) — Porto

Идентификаторы

NCT: NCT07070284 · ESCAPE10 STUDY

Первоисточники (государственные реестры)

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