Community Acquired Pneumonia in Older Adults

NCT04709978 | Completed FDA Drug

• 5 other identifiers: 2020-1121Protocol Version 11/3/22A534100SMPH/EMERG MEDA534255
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Aspiration Pneumonia

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Aspiration

  As defined by VFSS and radionuclide salivagram imaging studies.

  up to 6 months on study

Secondary Outcomes (10)

• 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

• 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

• Lung Ultrasound Findings for ED participants

  at ED visit, baseline

Study Arms (1)

Pneumonia

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.

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

Interventions

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.

Pneumonia

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.

Pneumonia

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.

Also known as: bedside dysphagia screening; 3 ounce water swallow test

Pneumonia

Sputum Culture DIAGNOSTIC_TEST

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

Pneumonia

MeMed BV® DIAGNOSTIC_TEST

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

Pneumonia

Lung Ultrasound DIAGNOSTIC_TEST

To image the lungs (ED participants only)

Pneumonia

Respiratory Function Tests DIAGNOSTIC_TEST

To measure respiratory pressures.

Also known as: manometer, peak cough flow

Pneumonia

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Prisoner
• Non-English speaking
• Respiratory symptoms for 7 days or more
• Phone Recruitment
• 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
• Prisoner
• Non-English speaking

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Gordon and Betty Moore Foundation: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva and mouth swabs, blood samples

MeSH Terms

Conditions

Pneumonia; Pneumonia, Aspiration

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Michael Pulia, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: February 24, 2021
• Primary Completion: July 2, 2023
• Study Completion: July 2, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)