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NCT06092008 Clinical Trial

Performance of New Diagnostic Methods in Older Adults With Pneumonia

Pneumonia Clinical Trial

— PNEUMO  

Official title:
Establishing and Implementing Pneumonia Diagnosis in ED Older Adults: A Mixed Methods Approach

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06092008
Other study ID # 2022H0136
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2, 2022
Est. completion date June 30, 2027

Study information
Verified date October 2023
Source Ohio State University
Contact Michael Hill, RN
Phone 614-293-6185
Email michael.hill@osumc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Create a clinical diagnostic pathway for older ED adults with pneumonia and its subgroups (bacterial, viral, and co-infection) and determine whether novel biomarkers improve diagnostic accuracy. The investigators will conduct a prospective observational trial of 250 ED patients ≥65 years old with suspected pneumonia. The investigators will perform analyses overall and by subgroups, seeking common models to ease adoption.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date June 30, 2027
Est. primary completion date August 30, 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Adults aged 65 and older presenting to the ED with suspected pneumonia defined as (1) either a physician order for CXR OR CT OR a chief complaint consistent with dyspnea; AND (2) physician suspicion of pneumonia prior to ED testing (score of 2-5 on Likert scale) Exclusion Criteria: - inability to obtain consent from the patient or an LAR - active cancer - organ transplant - immunosuppression - trauma activation - suicidal ideation - incarceration - antibiotics in the last 14 days - a separate episode of lower respiratory illness in the last 30 days

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Ohio State University Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pneumonia Presence or absence of pneumonia based on adjudicator review of chart. The goal of the study is to create a diagnostic pathway for pneumonia in older adult emergency department patients. 3 years
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