Community-Acquired PneumoniaNCT07442656
Frailty and Outcomes in Older Emergency Department Patients With Pneumonia
An observational study of Community-Acquired Pneumonia and Fraility, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Pneumonia is one of the leading causes of infection-related mortality in the older population. Traditional severity scores used in emergency departments, such as the Pneumonia Severity Index (PSI) and CURB-65, primarily focus on acute physiological derangements and may not adequately capture biological reserve and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Community-Acquired Pneumonia, Fraility, Hospitalizations
- What is being tested?
- Clinical frailty scale and Clinical Frailty Scale (CFS)
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 30 Apr 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: Older adults aged 65 years and above presenting to a tertiary university hospital emergency department with a clinical and radiological diagnosis of pneumonia. The study population represents geriatric patients with acute infectious respiratory illness requiring emergency evaluation, including a wide range of comorbidity and functional status levels typical of real-world emergency department practice.
Who may be able to join
- Age ≥65 years
- Clinical and radiological diagnosis of pneumonia in the emergency department
- Ability to obtain informed consent from the patient or legal representative
- Availability of a caregiver or relative able to describe baseline functional status
Who cannot join
- Presentation with cardiopulmonary arrest or ongoing cardiopulmonary resuscitation at admission
- Confirmed COVID-19 pneumonia
- Inability to obtain reliable baseline functional history due to absence of an informant
- Refusal to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Özge Can
Izmir, Bornova, 35100
Özge Can, +902323902321, ozge.can@ege.edu.tr
About this study
Official title: Impact of Clinical Frailty Scale on Morbidity and Mortality in Older Adults Diagnosed With Pneumonia in the Emergency Department: A Prospective Observational Cohort Study
Pneumonia is one of the leading causes of infection-related mortality in the older population. Traditional severity scores used in emergency departments, such as the Pneumonia Severity Index (PSI) and CURB-65, primarily focus on acute physiological derangements and may not adequately capture biological reserve and frailty in older adults. Frailty is a geriatric syndrome reflecting increased vulnerability to stressors and reduced recovery capacity.
This prospective observational cohort study aims to evaluate the predictive value of the Clinical Frailty Scale (CFS) for in-hospital mortality, 30-day mortality, and morbidity in patients aged 65 years and older presenting to the emergency department with pneumonia. Additionally, the study will assess whether incorporating frailty assessment into existing pneumonia severity scores improves prognostic accuracy.
Read the detailed description
Pneumonia represents a major cause of hospitalization, intensive care admission, and mortality in older adults worldwide. Aging is associated with multimorbidity and immunosenescence, increasing vulnerability to infection and poor outcomes. Current risk stratification tools used in emergency departments, including PSI and CURB-65, are designed to estimate short-term mortality based on acute clinical variables. However, these tools may not fully reflect functional reserve and biological age.
Frailty is characterized by decreased physiological reserve and increased susceptibility to adverse outcomes. The Clinical Frailty Scale (CFS), based on the deficit accumulation model, provides a rapid bedside assessment of global functional status using a 9-point scale. Emerging evidence suggests that frailty is an independent predictor of mortality and morbidity in older emergency department populations.
This single-center prospective observational cohort study will be conducted in a tertiary university hospital emergency department. Patients aged ≥65 years with a clinical and radiological diagnosis of pneumonia will be enrolled consecutively. Demographic data, comorbidities, vital signs, and PSI scores will be recorded at presentation. Frailty will be assessed using the Clinical Frailty Scale at the bedside.
The primary outcomes are in-hospital mortality and 30-day mortality. Secondary outcomes include intensive care unit admission and need for mechanical ventilation. Statistical analysis will evaluate whether CFS independently predicts outcomes and whether adding frailty assessment to existing pneumonia severity scores improves prognostic performance.
- Conditions
- Community-Acquired Pneumonia, Fraility, Hospitalizations
- Being tested
- Clinical frailty scale, Clinical Frailty Scale (CFS)
- Keywords
- Fraility, Clinical Fraility Scale, Older adults, Geriatric Emergency Medicine
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical frailty scaleOther
Frailty assessment performed at emergency department presentation using the 9-point Clinical Frailty Scale.
Clinical Frailty Scale (CFS)Diagnostic test
The Clinical Frailty Scale (CFS) will be assessed on a 1-9 scale. The CFS score obtained at presentation will also be compared with the patient's baseline CFS prior to the onset of the current illness symptoms.
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital mortality
All-cause mortality occurring during the same hospital admission after emergency department presentation.
Measured: During index hospitalization (7 and 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Jan 2026
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Can. MD, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442656
- Sponsor's protocol ID
- 26-1.1T/96
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 2 Mar 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Frailty Scale on Morbidity and Mortality in Older Adults Diagnosed With Pneumonia in the Emergency Department: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07442656
- Acronym / sponsor ID
- 26-1.1T/96
- Conditions
- Community-Acquired Pneumonia, Fraility, Hospitalizations
- Keywords
- Fraility, Clinical Fraility Scale, Older adults, Geriatric Emergency Medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 2 Mar 2026 (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.
Pneumonia is one of the leading causes of infection-related mortality in the older population. Traditional severity scores used in emergency departments, such as the Pneumonia Severity Index (PSI) and CURB-65, primarily focus on acute physiological derangements and may not adequately capture biological reserve and frailty in older adults. Frailty is a geriatric syndrome reflecting increased vulnerability to stressors and reduced recovery capacity.
This prospective observational cohort study aims to evaluate the predictive value of the Clinical Frailty Scale (CFS) for in-hospital mortality, 30-day mortality, and morbidity in patients aged 65 years and older presenting to the emergency department with pneumonia. Additionally, the study will assess whether incorporating frailty assessment into existing pneumonia severity scores improves prognostic accuracy.
Detailed description
Pneumonia represents a major cause of hospitalization, intensive care admission, and mortality in older adults worldwide. Aging is associated with multimorbidity and immunosenescence, increasing vulnerability to infection and poor outcomes. Current risk stratification tools used in emergency departments, including PSI and CURB-65, are designed to estimate short-term mortality based on acute clinical variables. However, these tools may not fully reflect functional reserve and biological age.
Frailty is characterized by decreased physiological reserve and increased susceptibility to adverse outcomes. The Clinical Frailty Scale (CFS), based on the deficit accumulation model, provides a rapid bedside assessment of global functional status using a 9-point scale. Emerging evidence suggests that frailty is an independent predictor of mortality and morbidity in older emergency department populations.
This single-center prospective observational cohort study will be conducted in a tertiary university hospital emergency department. Patients aged ≥65 years with a clinical and radiological diagnosis of pneumonia will be enrolled consecutively. Demographic data, comorbidities, vital signs, and PSI scores will be recorded at presentation. Frailty will be assessed using the Clinical Frailty Scale at the bedside.
The primary outcomes are in-hospital mortality and 30-day mortality. Secondary outcomes include intensive care unit admission and need for mechanical ventilation. Statistical analysis will evaluate whether CFS independently predicts outcomes and whether adding frailty assessment to existing pneumonia severity scores improves prognostic performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults aged 65 years and above presenting to a tertiary university hospital emergency department with a clinical and radiological diagnosis of pneumonia. The study population represents geriatric patients with acute infectious respiratory illness requiring emergency evaluation, including a wide range of comorbidity and functional status levels typical of real-world emergency department practice.
Key inclusion criteria (4 listed)
- Age ≥65 years
- Clinical and radiological diagnosis of pneumonia in the emergency department
- Ability to obtain informed consent from the patient or legal representative
- Availability of a caregiver or relative able to describe baseline functional status
Key exclusion criteria (4 listed)
- Presentation with cardiopulmonary arrest or ongoing cardiopulmonary resuscitation at admission
- Confirmed COVID-19 pneumonia
- Inability to obtain reliable baseline functional history due to absence of an informant
- Refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical frailty scaleFrailty assessment performed at emergency department presentation using the 9-point Clinical Frailty Scale. | Other | – |
| Clinical Frailty Scale (CFS)The Clinical Frailty Scale (CFS) will be assessed on a 1-9 scale. The CFS score obtained at presentation will also be compared with the patient's baseline CFS prior to the onset of the current illness symptoms. | Diagnostic test | – |
Primary outcome
In hospital mortality
Time frame: During index hospitalization (7 and 14 days)
All-cause mortality occurring during the same hospital admission after emergency department presentation.
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 2 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-Acquired Pneumonia and Fraility, run by Ege University at 1 site in Turkey (Türkiye).
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 4 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Contact Özlem İnci, MD (902323902321, ozge.can@ege.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In hospital mortality (time frame: During index hospitalization (7 and 14 days)). 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 2 Mar 2026.