NCT06092008

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Dec 2022Jun 2027

Study Start

First participant enrolled

December 2, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

October 11, 2023

Last Update Submit

February 5, 2026

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 65 and older presenting to the Emergency Department

You may qualify if:

  • \- 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Michael Hill, RN

CONTACT

614-293-6185michael.hill@osumc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 23, 2023

Study Start

December 2, 2022

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

US(1)