Clinical trial NCT04709978: Community Acquired Pneumonia in Older Adults
Official title: Redefining Community Acquired Pneumonia in Older Adults: The Role and Impact of Aspiration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Aspiration Pneumonia
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Gordon and Betty Moore Foundation
First posted: 2021-01-14
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Aspiration
timeFrame: up to 6 months on study
Secondary outcomes:
measure: Salivary extensional viscosity
timeFrame: Any point during follow up within 6 months of index visit
measure: Salivary Substance P Concentration
timeFrame: Any point during follow up within 6 months of index visit
measure: Salivary pH
timeFrame: Any point during follow up within 6 months of index visit
measure: Recurrent pneumonia
timeFrame: Any point during follow up within 6 months of index visit
measure: Lung Ultrasound Findings for ED participants
timeFrame: at ED visit, baseline
measure: Patient Reported Swallowing Function as measured by physical symptoms on SWAL-QOL
timeFrame: at Point of Care visit, up to 6 months
measure: Percent Viral vs. Bacterial Infection for ED participants
timeFrame: at ED visit, baseline
measure: Respiratory Pressure
timeFrame: Any point during follow up within 6 months of index visit
measure: Peak Expiratory Flow (PEF)
timeFrame: Any point during follow up within 6 months of index visit
measure: Forced Expiratory Volume (FEV1)
timeFrame: Any point during follow up within 6 months of index visit
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael Pulia, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: