NCT04709978

Community Acquired Pneumonia in Older Adults

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia
• Aspiration Pneumonia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-02-24
• Primary completion: 2023-07-02
• Completion: 2023-07-02
• First posted: 2021-01-14
• Last updated: 2023-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study