Community Acquired Pneumonia in Older Adults

Pneumonia Clinical Trial

Official title:

Redefining Community Acquired Pneumonia in Older Adults: The Role and Impact of Aspiration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709978
• Other study ID #: 2020-1121
• Secondary ID: Protocol Version
• Status: Completed
• Start date: February 24, 2021
• Est. completion date: July 2, 2023

Study information

• Verified date: November 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 62 of these participants will be enrolled in a supplemental study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2, 2023
• Est. primary completion date: July 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Pneumonia
• Pneumonia, Aspiration

Intervention

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.
• 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.
• 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.
• Sputum Culture
Patients will have sputum collected during stay (ED participants only)
• MeMed BV®
A blood test to help determine if the infection is viral or bacterial (ED participants only)
• Lung Ultrasound
To image the lungs (ED participants only)
• Respiratory Function Tests
To measure respiratory pressures.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Gordon and Betty Moore Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Aspiration	As defined by VFSS and radionuclide salivagram imaging studies.	up to 6 months on study
Secondary	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
Secondary	Salivary Substance P Concentration	Substance P is a salivary protein	Any point during follow up within 6 months of index visit
Secondary	Salivary pH	Salivary pH will be measured using a digital pH meter.	Any point during follow up within 6 months of index visit
Secondary	Recurrent pneumonia	As assessed on medical chart review	Any point during follow up within 6 months of index visit
Secondary	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
Secondary	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
Secondary	Percent Viral vs. Bacterial Infection for ED participants	MeMed BV® test results for participants recruited in the ED.	at ED visit, baseline
Secondary	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
Secondary	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
Secondary	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