Performance of New Diagnostic Methods in Older Adults Wit... | NCT06092008

Studies
Performance of New Diagnostic Methods in Older Adults With Pneumonia

NCT06092008

Sponsor

Ohio State University

Status

Recruiting

Last Update Posted

Feb 6, 2026Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Pneumonia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2022Actual

Primary Completion Date

Sep 30, 2026Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Oct 11, 2023

First Submission Date that Met QC Criteria

Oct 17, 2023

First Posted Date

Oct 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2026

Last Update Posted Date

Feb 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Adults aged 65 and older presenting to the Emergency Department

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Hill, RN	Contact	614-293-6185		michael.hill@osumc.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University	Recruiting	Columbus	Ohio	43210	United States

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided