Community Acquired Pneumonia in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Aspiration Pneumonia
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Emergency Department (ED) Recruitment

Inclusion Criteria:

• 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

Exclusion Criteria:

• Prisoner
• Non-English speaking
• Respiratory symptoms for 7 days or more

Phone Recruitment

Inclusion Criteria:

• 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

Exclusion Criteria:

• Prisoner
• Non-English speaking

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: Videofluoroscopic Swallowing Study; Participants 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: Nuclear medicine pulmonary aspiration study; 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.; Diagnostic test: TOR-BSST and 3 oz Water Swallow; 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.; Other Names: bedside dysphagia screening; 3 ounce water swallow test; Diagnostic test: Sputum Culture; Patients will have sputum collected during stay (ED participants only); Diagnostic test: MeMed BV®; A blood test to help determine if the infection is viral or bacterial (ED participants only); Diagnostic test: Lung Ultrasound; To image the lungs (ED participants only); Diagnostic test: Respiratory Function Tests; To measure respiratory pressures.; Other Names: manometer; peak cough flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Aspiration	As defined by VFSS and radionuclide salivagram imaging studies.	up to 6 months on study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary extensional viscosity	Extensional viscosity will be determined using an extensional rheometer (Thermo-Fisher CaBER) and will be recorded 3 times per sample.	Any point during follow up within 6 months of index visit
Salivary Substance P Concentration	Substance P is a salivary protein	Any point during follow up within 6 months of index visit
Salivary pH	Salivary pH will be measured using a digital pH meter.	Any point during follow up within 6 months of index visit
Recurrent pneumonia	As assessed on medical chart review	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.	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.	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.	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.	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.	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.	Any point during follow up within 6 months of index visit

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Gordon and Betty Moore Foundation
• Investigators: Principal Investigator: Michael Pulia, MD, MS, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): July 2, 2023
• Study Completion (Actual): July 2, 2023

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Pneumonia, Aspiration
• Other Study ID Numbers: 2020-1121 (Other Identifier: M D Anderson Cancer Center); A534255 (Other Identifier: UW Madison); A534100 (Other Identifier: UW Madison); Protocol Version 11/3/22 (Other Identifier: UW Madison); SMPH/EMERG MED (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No