Severe Community-Acquired Pneumonia (sCAP)ESCAPE10NCT07070284
ESCAPE10: Epidemiology, Risk Factors, and Outcomes of Severe Community-acquired Pneumonia in Elderly Patients Acquired Pneumonia in Elderly Patients
An observational study of Severe Community-Acquired Pneumonia (sCAP) and Elderly Infection, run by Joan Sabater-Riera at 18 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Severe Community-Acquired Pneumonia (sCAP), Elderly Infection, Community-Acquired Infections
- How many people
- 500 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 1 May 2025to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
18 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 6 countries
France5 sites
Thibaut Fraisse
Alès, 30103
Centre Hospitalier Intercommunal Hôpitaux du Pays du Mont-Blanc - Site de Chamonix
Chamonix, 74400
Centre hospitalier Alpes Léman
Contamine-sur-Arve, 74130
Centre Hospitalier de Melun
Melun, 77000
Hôpital Bichat - Claude-Bernard
Paris, 75018
Italy5 sites
ASST del Garda - Ospedale Civile "La Memoria" di Gavardo
Gavardo, Lombardy, 25085
Azienda Ospedaliero-Universitaria di Modena
Modena, Emilia-Romagna, 41124
ARNAS Civico-Di Cristina-Benfratelli Hospital - Infectious Diseases Unit
Palermo, Sicily, 90127
Azienda Ospedaliero-Universitaria Pisana
Pisa, Tuscany, 56126
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Rome, Lazio, 00161
Spain5 sites
Hospital del Mar Barcelona
Barcelona, Catalonia, 08003
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, 20014
Bellvitge Universitary Hospital
L'Hospitalet de Llobregat, Barcelona, 08907
Corporació Sanitària Parc Taulí
Sabadell, Catalunuya, 08208
Hospital Universitario Virgen del Rocío
Seville, Andalusia, 41013
Croatia1 site
University Hospital for Infectious Diseases Dr. Fran Mihaljević
Zagreb, City of Zagreb, 10000
Portugal1 site
Centro Hospitalar Universitário de São João (CHUSJ)
Porto, 4200-319
About this study
Official title: Escape 10 Study: Epidemiology and Determinants of Outcomes of Severe Community-acquired Pneumonia in the Elderly
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.
- Conditions
- Severe Community-Acquired Pneumonia (sCAP), Elderly Infection, Community-Acquired Infections, Health Care Quality, Access, and Evaluation
- Medical subject headings
- Community-Acquired Pneumonia, Community-Acquired Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day All-Cause Mortality
Number of participants who die from any cause within 28 days from the date of hospital admission.
Measured: 28 days from admission
Secondary outcomes (8)
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.
Measured: From hospital admission through hospital discharge (average of 5 to 30 days)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 May 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Community-Acquired Pneumonia (sCAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joan Sabater-Riera
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Clinical Microbiology and Infectious Diseases, Hospital Universitari de Bellvitge
- Responsible party
- Sponsor-investigator, Joan Sabater-Riera, Hospital Universitari de Bellvitge
- Investigators
- Jordi Rello, phD, MD, Principal investigator, European Study Group Infections in the Elderly. ESCMID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070284
- Sponsor's protocol ID
- ESCAPE10 STUDY
- Acronym
- ESCAPE10
- Status last verified
- May 2026
- First submitted
- 7 Jun 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escape 10 Study: Epidemiology and Determinants of Outcomes of Severe Community-acquired Pneumonia in the Elderly
- ClinicalTrials.gov ID
- NCT07070284
- Acronym / sponsor ID
- ESCAPE10 / ESCAPE10 STUDY
- Conditions
- Severe Community-Acquired Pneumonia (sCAP), Elderly Infection, Community-Acquired Infections, Health Care Quality, Access, and Evaluation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Joan Sabater-RieraUniversity, hospital or other
- Collaborators
- European Society of Clinical Microbiology and Infectious Diseases, Hospital Universitari de Bellvitge
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
In-Hospital Mortality (All Cause)
Time frame: From hospital admission through hospital discharge (average of 5 to 30 days)
Pneumonia-Attributed In-Hospital Mortality
Time frame: From hospital admission through hospital discharge (average of 5 to 30 days)
Length of Hospital Stay (LOS)
Time frame: Through hospital discharge (average of 5 to 30 days)
Duration of ICU Stay
Time frame: Through ICU or High Dependency Unit (HDU) discharge (average of 2 to 15 days)
Duration of Mechanical Ventilation
Time frame: Through hospital discharge (average of 2 to 20 days)
Rate of Pneumonia-Related Complications
Time frame: From hospital admission to hospital discharge, up to a maximum of 30 days
Functional Status at Discharge
Time frame: At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course)
Cognitive Function at Discharge
Time frame: At hospital discharge (typically between Day 5 and Day 30 post-admission, depending on clinical course)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
Related trials for Severe Community-Acquired Pneumonia (sCAP)
RecruitingPhase 3
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
Community-acquired Pneumonia
Not yet recruitingObservational study
Epidemiology and Current Practices in Severe Community-Acquired Pneumonia
Severe Community-acquired Pneumonia (sCAP)
Not yet recruitingPhase 2/3
Randomized Adaptive Platform Trial of Pathogen-Directed Anti-inflammatory Therapy in Severe Community-Acquired Pneumonia(Core Protocal)
Severe Community-acquired Pneumonia (sCAP)
Not yet recruiting
Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in South Korea
Severe Community-acquired Pneumonia (sCAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jordi Rello, phD, MD principal investigator
European Study Group Infections in the Elderly. ESCMID
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Community-Acquired Pneumonia (sCAP) and Elderly Infection, run by Joan Sabater-Riera at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Italy, Spain, Croatia, Greece and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day All-Cause Mortality (time frame: 28 days from admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.