Skip to main content
Clinical Trials/NCT04709978
NCT04709978
Completed
Not Applicable

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

University of Wisconsin, Madison1 site in 1 country75 target enrollmentFebruary 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonia
Sponsor
University of Wisconsin, Madison
Enrollment
75
Locations
1
Primary Endpoint
Number of Participants with Aspiration
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 24, 2021
End Date
July 2, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • 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:
  • Non-English speaking

Outcomes

Primary Outcomes

Number of Participants with Aspiration

Time Frame: up to 6 months on study

As defined by VFSS and radionuclide salivagram imaging studies.

Secondary Outcomes

  • Lung Ultrasound Findings for ED participants(at ED visit, baseline)
  • Peak Expiratory Flow (PEF)(Any point during follow up within 6 months of index visit)
  • Forced Expiratory Volume (FEV1)(Any point during follow up within 6 months of index visit)
  • Salivary pH(Any point during follow up within 6 months of index visit)
  • Recurrent pneumonia(Any point during follow up within 6 months of index visit)
  • Percent Viral vs. Bacterial Infection for ED participants(at ED visit, baseline)
  • Salivary extensional viscosity(Any point during follow up within 6 months of index visit)
  • Salivary Substance P Concentration(Any point during follow up within 6 months of index visit)
  • Patient Reported Swallowing Function as measured by physical symptoms on SWAL-QOL(at Point of Care visit, up to 6 months)
  • Respiratory Pressure(Any point during follow up within 6 months of index visit)

Study Sites (1)

Loading locations...

Similar Trials