NCT00118651

Brief Summary

This is a study involving the emergency department and outpatient clinics of the David Grant United States Air Force (USAF) Medical Center, a tertiary care facility. Patients 18 years of age or older with acute respiratory symptoms and positive or equivocal chest radiographs from October 1, 2004 through May 31, 2005 will be included as positive cases. Controls will be randomly selected from a review of negative chest radiograph reports with a clinical history of an acute respiratory illness over the same time period. Once patients are appropriately identified as control or cases, outpatient charts will be reviewed to gather data on six clinical indicators. Sensitivities and specificities will be calculated for each clinical indicator, to determine which patients require chest radiographs in the setting of suspected community acquired pneumonia (CAP)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2004

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2005

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

July 1, 2005

Last Update Submit

April 15, 2020

Conditions

Keywords

pneumoniachest x-rayrespiratory infectionprediction rulethoracic imaging

Study Arms (2)

Positive cases

Positive radiographic findings were defined as the presence of a new air space opacities in the setting of acute respiratory symptoms. Patients with equivocal radiographic findings interpreted as "possible pneumonia" were considered positive cases

Control

Acute respiratory symptoms, negative chest radiographs, and a date of birth within five years of that of the positive case

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients (18 years of age or older) with acute respiratory symptoms and positive chest radiographs from October 2004 through April 2005 were enrolled as positive cases with an equal number of controls with acute respiratory symptoms but negative radiographs; controls were matched by age and date of radiograph

You may qualify if:

  • years of age or older
  • acute respiratory symptoms
  • positive chest radiographs
  • patients from outpatient clinics and the emergency department

You may not qualify if:

  • under the age of 18
  • suspected hospital-acquired pneumonia (positive radiographs within 10 days of hospital discharge)
  • suspected aspiration pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Grant USAF Medical Center

Travis Air Force Base, California, 94535, United States

Location

MeSH Terms

Conditions

PneumoniaRespiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • William T. O'Brien, D.O.

    David Grant USAF Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2005

First Posted

July 12, 2005

Study Start

October 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations