Skip to main content
OpenTrials
Completed

NCT Number: NCT04709978

Community Acquired Pneumonia in Older Adults

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pneumonia Aspiration Pneumonia Infections Lung Diseases Pneumonia, Aspiration Respiratory Tract Diseases Respiratory Tract Infections

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videofluoroscopic Swallowing Study

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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.

Other names: bedside dysphagia screening; 3 ounce water swallow test

Sputum culture

Diagnostic Test

Patients will have sputum collected during stay (ED participants only)

MeMed BV®

Diagnostic Test

A blood test to help determine if the infection is viral or bacterial (ED participants only)

Lung Ultrasound

Diagnostic Test

To image the lungs (ED participants only)

Respiratory function tests

Diagnostic Test

To measure respiratory pressures.

Other names: manometer, peak cough flow

Primary outcomes

  1. Number of Participants with Aspiration

    Time frame: up to 6 months on study

    As defined by VFSS and radionuclide salivagram imaging studies.

Secondary outcomes

  1. Salivary extensional viscosity

    Time frame: Any point during follow up within 6 months of index visit

    Extensional viscosity will be determined using an extensional rheometer (Thermo-Fisher CaBER) and will be recorded 3 times per sample.

  2. Salivary Substance P Concentration

    Time frame: Any point during follow up within 6 months of index visit

    Substance P is a salivary protein

  3. Salivary pH

    Time frame: Any point during follow up within 6 months of index visit

    Salivary pH will be measured using a digital pH meter.

  4. Recurrent pneumonia

    Time frame: Any point during follow up within 6 months of index visit

    As assessed on medical chart review

  5. Lung Ultrasound Findings for ED participants

    Time frame: at ED visit, baseline

    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.

  6. Patient Reported Swallowing Function as measured by physical symptoms on SWAL-QOL

    Time frame: at Point of Care visit, up to 6 months

    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.

  7. Percent Viral vs. Bacterial Infection for ED participants

    Time frame: at ED visit, baseline

    MeMed BV® test results for participants recruited in the ED.

  8. Respiratory Pressure

    Time frame: Any point during follow up within 6 months of index visit

    Maximum expiratory pressure and maximum inspiratory pressure will be measured using a handheld digital manometer. This test will take approximately 5 minutes.

  9. Peak Expiratory Flow (PEF)

    Time frame: Any point during follow up within 6 months of index visit

    A handheld digital peak cough flow meter will be used to assess PEF to quantify cough function. This test will take approximately 3 minutes.

  10. Forced Expiratory Volume (FEV1)

    Time frame: Any point during follow up within 6 months of index visit

    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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Gordon and Betty Moore Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 14, 2021
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.