PneumoniaNCT04709978
Community Acquired Pneumonia in Older Adults
An observational study of Pneumonia and Aspiration Pneumonia, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will utilize diagnostic imaging and salivary biomarkers to estimate the prevalence of aspiration in older adults with suspected community-acquired bacterial pneumonia (CABP). 150 participants over the age of 60 diagnosed with pneumonia will be recruited into this study. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pneumonia, Aspiration Pneumonia
- What is being tested?
- Videofluoroscopic Swallowing Study, Nuclear medicine pulmonary aspiration study and TOR-BSST and 3 oz Water Swallow
- Type of treatment
- Pill or oral medicine
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 2 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recruited from the UW Emergency Department and via phone, 60 years of age or older diagnosed with or treated for pneumonia in the past 6 months.
Who may be able to join
- 60 years of age or older
- Patient has clinical criteria for pneumonia or is being treated for pneumonia as defined by abnormal chest imaging or receiving antibiotics for a chest infection or the provider thinks the patient has pneumonia or is planning to treat the patient for pneumonia.
- Patient is clinically stable and able to safely drink water, per the emergency department provider
- Ability to provide consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient
- 60 years of age and older
- Patient was diagnosed with or treated for pneumonia at UW Health in the past 6 months
- Ability to provide consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient
Who cannot join
- Prisoner
- Non-English speaking
- Respiratory symptoms for 7 days or more
- Phone Recruitment
- Prisoner
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Redefining Community Acquired Pneumonia in Older Adults: The Role and Impact of Aspiration
This study will utilize diagnostic imaging and salivary biomarkers to estimate the prevalence of aspiration in older adults with suspected community-acquired bacterial pneumonia (CABP). 150 participants over the age of 60 diagnosed with pneumonia will be recruited into this study. 62 of these participants will be enrolled in a supplemental study.
Read the detailed description
Pneumonia is the most common infectious cause of mortality in older adults. Standard practice for older adults with pneumonia involves hospitalization and antibiotics. However, recent studies suggest that a significant portion of suspected community-acquired bacterial pneumonia (CABP) cases may actually be due to distinct, dysphagia-related aspiration syndromes (e.g. aspiration pneumonia, pneumonitis).
The main study will will assess whether salivary biomarkers (viscoelasticity, substance P) and swallowing function tests can be used to help differentiate CABP from aspiration-related syndromes. The following aims will be completed:
- Aim 1: Compare salivary properties and health outcomes among older adults with aspiration related pneumonia mimics and those with infectious pneumonia
- Aim 2: Compare appearance of lung ultrasound findings among older adults with aspiration related pneumonia mimics and those with infectious pneumonia.
- Aim 3: Describe dysphagia screening results, patient reported swallowing function, salivary properties, oral/nasopharyngeal microbiome profiles, in older adults with pneumonia presenting to the ED.
- Aim 4: Assess the potential impact of the MeMed BV® test's result on patient management decision making, including antibiotic prescribing and disposition.
A supplemental study will be the first to utilize diagnostic imaging (videofluoroscopic evaluation of swallowing and radionuclide salivagram) to estimate the prevalence of aspiration in older adults with suspected CABP.
- Aim 1: Determine the prevalence of dysphagia-related aspiration among older adults with pneumonia.
- Conditions
- Pneumonia, Aspiration Pneumonia
- Being tested
- Videofluoroscopic Swallowing Study, Nuclear medicine pulmonary aspiration study, TOR-BSST and 3 oz Water Swallow, Sputum Culture, MeMed BV®
- Medical subject headings
- Pneumonia, Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videofluoroscopic Swallowing StudyDiagnostic test
Participants enrolled in supplemental study will swallow different barium containing liquid and food boluses types that are captured on fluoroscopic imaging in real time.
Nuclear medicine pulmonary aspiration studyDiagnostic test
Participants enrolled in supplemental study will be administered radiotracer (Tc-99m-Sulfur Colloid) orally and static images of the chest will then be obtained at specified intervals over the next 2 hours to determine location of the radiotracer.
TOR-BSST and 3 oz Water SwallowDiagnostic test
Also called bedside dysphagia screening; 3 ounce water swallow test
The research specialist will conduct ten 1 tsp water swallows, one cup sip of water and a 3 ounce water swallow test with the patient. After each swallow, the participant is asked to say "ah" so that their voice quality can be assessed.
Sputum CultureDiagnostic test
Patients will have sputum collected during stay (ED participants only)
MeMed BV®Diagnostic test
A blood test to help determine if the infection is viral or bacterial (ED participants only)
Lung UltrasoundDiagnostic test
To image the lungs (ED participants only)
Respiratory Function TestsDiagnostic test
Also called manometer, peak cough flow
To measure respiratory pressures.
| Study group | Role | What they receive |
|---|---|---|
| Pneumonia | Participants will be over the age of 60 and diagnosed with pneumonia in the UW Emergency Department or treated for pneumonia in the past 6 months. Receives: Diagnostic Test: Videofluoroscopic Swallowing Study; Diagnostic Test: Nuclear medicine pulmonary aspiration study; Diagnostic Test: TOR-BSST and 3 oz Water Swallow; Diagnostic Test: Sputum Culture; Diagnostic Test: MeMed BV®; Diagnostic Test: Lung Ultrasound; Diagnostic Test: Respiratory Function Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Aspiration
As defined by VFSS and radionuclide salivagram imaging studies.
Measured: up to 6 months on study
Secondary outcomes (10)
Salivary extensional viscosity
Extensional viscosity will be determined using an extensional rheometer (Thermo-Fisher CaBER) and will be recorded 3 times per sample.
Measured: Any point during follow up within 6 months of index visit
Salivary Substance P Concentration
Substance P is a salivary protein
Measured: Any point during follow up within 6 months of index visit
Salivary pH
Salivary pH will be measured using a digital pH meter.
Measured: Any point during follow up within 6 months of index visit
Recurrent pneumonia
As assessed on medical chart review
Measured: Any point during follow up within 6 months of index visit
Lung Ultrasound Findings for ED participants
Lung ultrasound exams will be compared between older adults with aspiration related pneumonia mimics and those with infectious pneumonia. Interpretation of ultrasound images will be performed by two ultrasound fellowship trained EM faculty, blinded to any clinical information. Each lung ultrasound view captured will be reviewed and interpreted descriptively. Lung ultrasound findings will be described with the following features: crisp or irregular pleural line, A line artifacts, isolated Z line artifacts, static air bronchograms, dynamic air bronchograms, tissue-like consolidation without bronchograms, coalescent B lines (presence and how many per interspace), discrete B lines (presence and how many per interspace), subpleural hypoechoic consolidation, and pleural effusion.
Measured: at ED visit, baseline
Patient Reported Swallowing Function as measured by physical symptoms on SWAL-QOL
All participants will complete self report surveys at their first study visit. The physical symptoms question on the SWAL-QOL asks the participant to identify how often they experienced specific symptoms in the past month, from 1 (almost always) to 5 (never). The total score is transposed to 0-100 with higher scores indicating better swallowing function.
Measured: at Point of Care visit, up to 6 months
Percent Viral vs. Bacterial Infection for ED participants
MeMed BV® test results for participants recruited in the ED.
Measured: at ED visit, baseline
Respiratory Pressure
Maximum expiratory pressure and maximum inspiratory pressure will be measured using a handheld digital manometer. This test will take approximately 5 minutes.
Measured: Any point during follow up within 6 months of index visit
Peak Expiratory Flow (PEF)
A handheld digital peak cough flow meter will be used to assess PEF to quantify cough function. This test will take approximately 3 minutes.
Measured: Any point during follow up within 6 months of index visit
Forced Expiratory Volume (FEV1)
A handheld digital peak cough flow meter will be used to assess forced expiratory volume (FEV1) to quantify cough function. This test will take approximately 3 minutes.
Measured: Any point during follow up within 6 months of index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start24 Feb 2021
- Primary completion2 Jul 2023
- Study completion2 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Responsible party
- Sponsor
- Investigators
- Michael Pulia, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709978
- Sponsor's protocol ID
- 2020-1121
- Other IDs
- Protocol Version 11/3/22, A534100, SMPH/EMERG MED, A534255
- Status last verified
- Nov 2023
- First submitted
- 12 Jan 2021
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redefining Community Acquired Pneumonia in Older Adults: The Role and Impact of Aspiration
- ClinicalTrials.gov ID
- NCT04709978
- Acronym / sponsor ID
- 2020-1121
- Conditions
- Pneumonia, Aspiration Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 2 Jul 2023 (actual)
- Study completion
- 2 Jul 2023 (actual)
- First posted
- 14 Jan 2021 (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.
This study will utilize diagnostic imaging and salivary biomarkers to estimate the prevalence of aspiration in older adults with suspected community-acquired bacterial pneumonia (CABP). 150 participants over the age of 60 diagnosed with pneumonia will be recruited into this study. 62 of these participants will be enrolled in a supplemental study.
Detailed description
Pneumonia is the most common infectious cause of mortality in older adults. Standard practice for older adults with pneumonia involves hospitalization and antibiotics. However, recent studies suggest that a significant portion of suspected community-acquired bacterial pneumonia (CABP) cases may actually be due to distinct, dysphagia-related aspiration syndromes (e.g. aspiration pneumonia, pneumonitis).
The main study will will assess whether salivary biomarkers (viscoelasticity, substance P) and swallowing function tests can be used to help differentiate CABP from aspiration-related syndromes. The following aims will be completed:
- Aim 1: Compare salivary properties and health outcomes among older adults with aspiration related pneumonia mimics and those with infectious pneumonia
- Aim 2: Compare appearance of lung ultrasound findings among older adults with aspiration related pneumonia mimics and those with infectious pneumonia.
- Aim 3: Describe dysphagia screening results, patient reported swallowing function, salivary properties, oral/nasopharyngeal microbiome profiles, in older adults with pneumonia presenting to the ED.
- Aim 4: Assess the potential impact of the MeMed BV® test's result on patient management decision making, including antibiotic prescribing and disposition.
A supplemental study will be the first to utilize diagnostic imaging (videofluoroscopic evaluation of swallowing and radionuclide salivagram) to estimate the prevalence of aspiration in older adults with suspected CABP.
- Aim 1: Determine the prevalence of dysphagia-related aspiration among older adults with pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumonia | – | Diagnostic Test: Videofluoroscopic Swallowing Study, Diagnostic Test: Nuclear medicine pulmonary aspiration study, Diagnostic Test: TOR-BSST and 3 oz Water Swallow, Diagnostic Test: Sputum Culture, Diagnostic Test: MeMed BV®, Diagnostic Test: Lung Ultrasound, Diagnostic Test: Respiratory Function TestsParticipants will be over the age of 60 and diagnosed with pneumonia in the UW Emergency Department or treated for pneumonia in the past 6 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited from the UW Emergency Department and via phone, 60 years of age or older diagnosed with or treated for pneumonia in the past 6 months.
Key inclusion criteria (7 listed)
- 60 years of age or older
- Patient has clinical criteria for pneumonia or is being treated for pneumonia as defined by abnormal chest imaging or receiving antibiotics for a chest infection or the provider thinks the patient has pneumonia or is planning to treat the patient for pneumonia.
- Patient is clinically stable and able to safely drink water, per the emergency department provider
- Ability to provide consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient
- 60 years of age and older
Key exclusion criteria (6 listed)
- Prisoner
- Non-English speaking
- Respiratory symptoms for 7 days or more
- Phone Recruitment
- Prisoner
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 |
|---|---|---|
| Videofluoroscopic Swallowing StudyParticipants enrolled in supplemental study will swallow different barium containing liquid and food boluses types that are captured on fluoroscopic imaging in real time. | Diagnostic test | Pneumonia |
| Nuclear medicine pulmonary aspiration studyParticipants enrolled in supplemental study will be administered radiotracer (Tc-99m-Sulfur Colloid) orally and static images of the chest will then be obtained at specified intervals over the next 2 hours to determine location of the radiotracer. | Diagnostic test | Pneumonia |
| TOR-BSST and 3 oz Water SwallowAlso: bedside dysphagia screening; 3 ounce water swallow testThe research specialist will conduct ten 1 tsp water swallows, one cup sip of water and a 3 ounce water swallow test with the patient. After each swallow, the participant is asked to say "ah" so that their voice quality can be assessed. | Diagnostic test | Pneumonia |
| Sputum CulturePatients will have sputum collected during stay (ED participants only) | Diagnostic test | Pneumonia |
| MeMed BV®A blood test to help determine if the infection is viral or bacterial (ED participants only) | Diagnostic test | Pneumonia |
| Lung UltrasoundTo image the lungs (ED participants only) | Diagnostic test | Pneumonia |
| Respiratory Function TestsAlso: manometer, peak cough flowTo measure respiratory pressures. | Diagnostic test | Pneumonia |
Primary outcome
Number of Participants with Aspiration
Time frame: up to 6 months on study
As defined by VFSS and radionuclide salivagram imaging studies.
10 secondary outcomes
Salivary extensional viscosity
Time frame: Any point during follow up within 6 months of index visit
Salivary Substance P Concentration
Time frame: Any point during follow up within 6 months of index visit
Salivary pH
Time frame: Any point during follow up within 6 months of index visit
Recurrent pneumonia
Time frame: Any point during follow up within 6 months of index visit
Lung Ultrasound Findings for ED participants
Time frame: at ED visit, baseline
Patient Reported Swallowing Function as measured by physical symptoms on SWAL-QOL
Time frame: at Point of Care visit, up to 6 months
Percent Viral vs. Bacterial Infection for ED participants
Time frame: at ED visit, baseline
Respiratory Pressure
Time frame: Any point during follow up within 6 months of index visit
Peak Expiratory Flow (PEF)
Time frame: Any point during follow up within 6 months of index visit
Forced Expiratory Volume (FEV1)
Time frame: Any point during follow up within 6 months of index visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- 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. This study is not recruiting at the moment.
Michael Pulia, MD, MS principal investigator
University of Wisconsin, Madison
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 Pneumonia and Aspiration Pneumonia, run by University of Wisconsin, Madison at 1 site in United States.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 15 Nov 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Aspiration (time frame: up to 6 months on study). 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 Nov 2023.