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PNEUMO: Performance of New Diagnostic Methods in Older Adults With Pneumonia

Sponsor
Ohio State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06092008
Collaborator
(none)
250
Enrollment
1
Location
54.9
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Establishing and Implementing Pneumonia Diagnosis in ED Older Adults: A Mixed Methods Approach
    Actual Study Start Date :
    Dec 2, 2022
    Anticipated Primary Completion Date :
    Aug 30, 2025
    Anticipated Study Completion Date :
    Jun 30, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Pneumonia [3 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ohio State University Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Katherine Buck, Assistant Professor, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT06092008
    Other Study ID Numbers:
    • 2022H0136
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumonia

    Study Results

    No Results Posted as of Oct 23, 2023