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PneumoniaNCT00118651

Clinical Indicators of Radiographic Findings in Patients With Suspected Community-Acquired Pneumonia

An observational study of Pneumonia, run by David Grant U.S. Air Force Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pneumonia
How many people
350 participants
Where
1 siteUnited States
Study dates
Oct 2004to Apr 2005
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • David Grant USAF Medical Center

    Travis Air Force Base, California, 94535

Other trials in United States

About this study

Official title: Clinical Indicators of Radiographic Findings in Patients With Suspected Community-Acquired Pneumonia: Who Needs a Chest X-Ray?

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)

Read the detailed description

This was a retrospective study designed to evaluate the efficacy of six clinical indicators to predict the presence of pulmonary infiltrates on chest radiography.

The study population will include a convenience sample of David Grant Air Force Medical Center patients that meet study criteria. Adult patients (18 years of age or older) with acute respiratory symptoms and positive chest radiographs from October 2004 through April 2005 will be enrolled as positive cases. There will be an equal number of controls with acute respiratory symptoms but negative radiographs. Controls will be matched by age and date of radiograph. Patients/Cases with suspected hospital-acquired (positive radiographs within 10 days of hospital discharge) or aspiration pneumonia will be excluded

Six clinical indicators were selected based on the cumulative results of seminal studies that included: cough, sputum production, temperature, heart rate, respiratory rate, and findings on physical examination. Abnormal vital signs were defined as temperature of 100.5 degrees Fahrenheit (38 degrees Celsius) or greater, heart rate greater than or equal to 100 beats per minute, and respiratory rate greater than 20 breaths per minute. Positive physical examination findings consisted of the presence of crackles, decreased breath sounds, dullness to percussion, egophony, or rhonchi

Outpatient emergency room physicians will record data regarding the clinical indicators prior to obtaining chest radiographs; thus, they will be blinded to the radiographic findings. All chests radiographs will be subsequently interpreted by a board-certified radiologist blinded to the clinical findings. Positive radiographic findings will be 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" will be considered positive cases. For each positive case, a single control was randomly selected from a list of eligible controls with acute respiratory symptoms, negative chest radiographs, and a date of birth within five years of that of the positive case.

Once patients are appropriately identified as cases or controls, outpatient charts will be reviewed to gather data regarding the six clinical indicators will be entered into the study database for analysis upon completion of the study. The sample size necessary to predict the proportion of patients with CAP who have all six clinical indicators was calculated as 385, assuming 95% confidence level and a 5% margin of error. Sample size estimates assume a random sample, which is not possible for us to obtain in this study; any conclusion that we draw will thus e cautiously interpreted. We will conduct this study for a minimum of one year with the intent to continue until a sample size of at least 385 is obtained. Upon completion of the study sensitivities and specificities and accompanying 95% confidence intervals for clinical indicators will be made to determine which combination of indicators best predicts the presence of pulmonary infiltrates in patients with CAP. Further analysis will be made within specific age groups (e.g., 18-40, 41-60, older than 60) and amongst those patients with pre-existing pulmonary disease

Conditions
Pneumonia
Keywords
pneumonia, chest x-ray, respiratory infection, prediction rule, thoracic imaging
Medical subject headings
Pneumonia, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00118651
Study groupRoleWhat they receive
Positive casesPositive 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
ControlAcute respiratory symptoms, negative chest radiographs, and a date of birth within five years of that of the positive case

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionApr 2005
  4. Study completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118651
Sponsor's protocol ID
FDG20040023H
Status last verified
Apr 2020
First submitted
1 Jul 2005
Last updated
17 Apr 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia, run by David Grant U.S. Air Force Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.

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