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Community Acquired Pneumonia in Older Adults

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Pneumonia
Aspiration Pneumonia

Treatments

Diagnostic Test: Nuclear medicine pulmonary aspiration study
Diagnostic Test: Respiratory Function Tests
Diagnostic Test: Lung Ultrasound
Diagnostic Test: TOR-BSST and 3 oz Water Swallow
Diagnostic Test: Videofluoroscopic Swallowing Study
Diagnostic Test: Sputum Culture
Diagnostic Test: MeMed BV®

Study type

Observational

Funder types

Other

Identifiers

NCT04709978
A534100 (Other Identifier)
SMPH/EMERG MED (Other Identifier)
Protocol Version 11/3/22 (Other Identifier)
A534255 (Other Identifier)
2020-1121

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

75 participants in 1 patient group

Pneumonia
Description:
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.
Treatment:
Diagnostic Test: Videofluoroscopic Swallowing Study
Diagnostic Test: Nuclear medicine pulmonary aspiration study
Diagnostic Test: MeMed BV®
Diagnostic Test: TOR-BSST and 3 oz Water Swallow
Diagnostic Test: Lung Ultrasound
Diagnostic Test: Respiratory Function Tests
Diagnostic Test: Sputum Culture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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