Recruiting

Diagnostic Methods

Sponsor:

Ohio State University

Code:

NCT06092008

Conditions

Pneumonia

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Pneumonia

Study ID

NCT06092008

Start date

Dec 2, 2022

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Pneumonia [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Ohio State University

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-02-06.