An observational study in Aspiration Pneumonias, sponsored by Region Örebro County. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Region Örebro County · Observational
Aspiration pneumonia is a lung infection that can occur when food, liquid, saliva, or material from the stomach enters the airways. It is an important health problem, particularly among older adults and people with swallowing difficulties, neurological conditions, frailty, or reduced functional ability. Diagnosis can be challenging, and patients may differ in their risk factors, investigations, treatment, and outcomes.
The ASPEN study (Aspiration Pneumonia Evaluation Network) is a retrospective observational study of adults aged 18 years or older who were hospitalized in Region Örebro County, Sweden, with a registered diagnosis of aspiration pneumonia between September 2024 and September 2026.
The researchers will review existing medical records and collect information using a structured data collection form. Information will include patients' age and other characteristics, living situation and functional status, underlying diseases, risk factors for aspiration, clinical findings, imaging, microbiological investigations, antibiotic treatment, other healthcare interventions, and outcomes.
The study will describe the characteristics of patients hospitalized with aspiration pneumonia, how the condition is investigated and treated in routine clinical practice, and how patients' hospital stays and subsequent outcomes develop. Outcomes of interest include clinical deterioration, length of hospital stay, discharge destination, readmission, a new documented episode of aspiration pneumonia, and death within 90 days, where information is available.
The study will also explore associations between patient characteristics, clinical features, investigations, treatment patterns, and outcomes. As this is an observational study based on existing medical records, it is not designed to establish whether a particular treatment causes better or worse outcomes.
The overall aim is to improve knowledge of aspiration pneumonia and provide a foundation for future research, with particular attention to older adults, functional ability, and healthcare needs.
Background
Aspiration pneumonia is a clinically important condition in adults, particularly in older people and individuals with dysphagia, neurological disease, frailty, reduced functional ability, and other comorbidities. The diagnosis may be difficult to establish because aspiration is not always witnessed and documentation varies between patients and clinical settings. Diagnostic investigations, microbiological sampling, and antibiotic treatment may also vary in routine clinical practice.
A systematic description of patient characteristics, aspiration-related risk factors, diagnostic approaches, treatment patterns, and clinical outcomes may help identify gaps in clinical documentation and areas for future research. This is particularly relevant to older adults, in whom an episode of pneumonia may be associated with functional decline, prolonged hospitalization, increased care needs, and recurrent healthcare contacts.
Study design and setting
ASPEN (Aspiration Pneumonia Evaluation Network) is a retrospective, observational cohort study conducted in Region Örebro County, Sweden. The study uses existing medical records and does not assign interventions or alter patients' clinical care.
The study population comprises adults aged 18 years or older hospitalized during the period September 2024 through September 2026 with a registered diagnosis of aspiration pneumonia. Patients will be identified through diagnostic coding. The planned primary cohort includes each eligible patient once; subsequent admissions will be handled as follow-up events rather than as new primary cohort observations.
Data collection
Data will be collected through structured review of existing medical records using a predefined data collection form. Variables will include:
Demographic characteristics, living situation, functional status, cognition, communication, nutritional status, and relevant comorbidities.
Risk factors for aspiration and the documentation and classification of the suspected or documented aspiration event.
Clinical presentation, vital signs, laboratory results, radiological findings, and microbiological investigations.
Antibiotic treatment, including antibiotic selection, broad- or narrow-spectrum treatment, anaerobic coverage, treatment duration, changes in treatment, and treatment at discharge where documented.
Other healthcare interventions, clinical deterioration, level of care, intensive or intermediate care, and length of hospital stay.
Discharge destination and follow-up outcomes, including readmission, a new documented episode of aspiration pneumonia, and death within 90 days, where information is available in the records.
Only information documented in the medical record will be recorded. Missing or undocumented information will not be inferred by the reviewer.
Outcomes and analyses
The study will primarily provide a descriptive characterization of the cohort and its clinical course. Analyses will summarize patient characteristics, aspiration-related risk factors, diagnostic investigations, microbiological findings, antibiotic treatment patterns, healthcare utilization, and clinical outcomes.
Exploratory analyses will examine associations between patient and disease characteristics, diagnostic findings, treatment patterns, and documented outcomes where the available data and number of outcome events permit. Antibiotic treatment patterns, including anaerobic coverage and treatment duration, will be described to characterize clinical practice and variation. The study is not designed to establish causal treatment effects or determine which antibiotic regimen is superior.
Ethical considerations
The study involves retrospective review of existing medical records. Ethical review and the necessary approvals will be obtained before the medical record review begins. Data will be handled in accordance with applicable Swedish requirements for research ethics, confidentiality, and personal data protection. Study data will be coded using study-specific identifiers, and direct identifiers will not be included in the analysis dataset.
Purpose and expected contribution
The study aims to provide a structured description of adults hospitalized with aspiration pneumonia in Region Örebro County. It is expected to identify patterns in patient characteristics, diagnostic practice, treatment, clinical course, and outcomes, as well as limitations in the completeness of routinely documented data. The findings will inform future research and the development of more standardized data collection, with particular relevance to older adults, functional outcomes, and healthcare needs.
73 studies on the registry are indexed under Pneumonia, Aspiration; 12 are open to participants now.
This study's planned enrollment of 300 is above the median of 93 across 28 observational studies indexed under Pneumonia, Aspiration.
Browse Pneumonia, Aspiration studies →Region Örebro County is the lead sponsor of 125 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of adults aged 18 years or older hospitalized in Region Örebro County, Sweden, with a registered diagnosis of aspiration pneumonia during September 2024 through September 2026. Patients will be identified retrospectively through medical records and diagnostic coding. The study will describe patient characteristics, aspiration risk factors, diagnostic findings, antibiotic treatment, and clinical outcomes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Patients transferred to or from another hospital when the transfer results in insufficient medical record data to assess the study variables and follow-up outcomes.
Adults aged 18 years or older hospitalized in Region Örebro County, Sweden, with a registered diagnosis of aspiration pneumonia during September 2024 through September 2026. Eligible patients will be identified through diagnostic coding and described using retrospectively collected medical record data. Each patient will be included once in the primary cohort; subsequent admissions will be handled as follow-up events.
Drug: Antibiotic Treatment in Routine Clinical Care
Antibiotic treatment is not assigned by the study. Existing medical records will be reviewed to describe antibiotic treatment provided as part of routine clinical care, including antibiotic selection, broad- or narrow-spectrum treatment, anaerobic coverage, treatment duration, changes in treatment, and treatment at discharge where documented. These data will be used to characterize clinical practice and variation in treatment patterns. The study is not designed to establish causal treatment effects or determine the superiority of any antibiotic regimen.Kopiera beskrivning
Also known as: Antibiotics; Antimicrobial therapy
All-cause mortality within 30 days
Proportion of patients who die from any cause within 30 days of the index hospital admission for aspiration pneumonia.
Time frame: Within 30 days after the date of the index hospital admission.
In-hospital clinical deterioration
In-hospital clinical deterioration during the index hospital admission.
Time frame: From the date of index hospital admission until discharge from the index hospitalization, up to a maximum of 90 days.
All-cause mortality within 90 days
All-cause mortality within 90 days
Time frame: From the date of the index hospital admission through 90 days after admission.
Hospital readmission within 90 days
Proportion of patients with at least one hospital readmission within 90 days after discharge from the index hospitalization.
Time frame: Up to 90 days after discharge from the index hospitalization.
Length of hospital stay
Duration of the hospital admission, measured in days from hospital admission to hospital discharge.
Time frame: From hospital admission to discharge for the index admission.
New documented aspiration pneumonia within 90 days
Proportion of patients with at least one new episode of aspiration pneumonia documented in the medical record within 90 days after discharge from the index hospital admission.
Time frame: From the date of the index hospital admission through 90 days after admission.
Plan to share: No — Individual participant data will not be shared with other researchers. The study uses data extracted retrospectively from medical records, and sharing individual-level data is not planned due to patient confidentiality, data protection requirements, and applicable regional regulations. Only aggregated study results may be reported in scientific publications.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Mar 2027, 1 month later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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