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Role of Chest Ultrasound in Diagnosing and Follow-up of Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00808457
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : August 15, 2011
Information provided by:

Study Description
Brief Summary:

The study of a large number of patients (at least 200 patients) from several European centres aims to investigate the value of chest ultrasound in diagnosing and checking the course of pneumonia as compared to a chest X-ray film in two planes and - in case of a controversial X-ray finding- as compared to low-dose CT.

An X-ray finding is regarded controversial, if infiltrates cannot be reliably excluded or not reliably represented and if a definite diagnosis is, thus, not possible. A low-dose CT is indicated even in case of a positive chest ultrasound and negative X-ray finding. Sonographic recording and characterization of pneumonic infiltrates is performed both at the time of diagnosing and in the further course under therapy.

Condition or disease

Detailed Description:

The primary target criterion is

• Assessing the sensitivity of chest ultrasound in diagnosing pneumonia.

Secondary target criteria comprise

  • Assessing specificity, negative and positive predictive value of chest ultrasound at the time of diagnosing,
  • Characterizing pneumonic infiltrates at the time of diagnosing and further course,
  • Describing the association between clinical, X-ray and sonographic findings in the course of pneumonia.

The tertiary target criterion includes

• Characterizing the range of pathogens detected by microbiological examination.

Study Design

Study Type : Observational
Actual Enrollment : 397 participants
Time Perspective: Prospective
Official Title: Role of Chest Ultrasound in Diagnosing and Follow-up of Pneumonia. Prospective Comparison Between X-ray Chest Film in Two Planes and "Low-dose" Spiral Computed Tomography
Study Start Date : September 2007
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

patients with suspected pneumonia

Outcome Measures

Primary Outcome Measures :
  1. sensitivity of chest ultrasound in diagnosing pneumonia [ Time Frame: baseline diagnostic ]

Secondary Outcome Measures :
  1. Specificity [ Time Frame: baseline diagnostic ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with clinically suspected community-acquired pneumonia.

Inclusion Criteria:

Patients with clinically suspected CAP who received no antibiotic treatment yet

  • Patients in whom a chest X-ray in 2 planes was already performed, can be included in the study, if chest ultrasound is performed within 24 hours after X-ray and if the X-ray finding is neither available to nor known to the examiner doing the ultrasound examination.
  • Age > 18 years
  • Patient's declaration of consent is available.

Exclusion Criteria:

  • Patients with HAP
  • Age <18 years
  • Patients in whom the time difference between chest ultrasound and chest X-ray in 2 planes is more than 24 hours
  • Patients whose X-ray findings are with the examiner doing the ultrasound or are known to him
  • Pregnancy and lactation
  • Missing declaration of consent by the patient.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808457

Pneumology, Friedrich-Schiller University Jena
Jena, Thüringen, Germany, 07740
Sponsors and Collaborators
University of Jena
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. med. Angelika Reißig, Pneumology, Friedrich-Schiller University Jena
ClinicalTrials.gov Identifier: NCT00808457     History of Changes
Other Study ID Numbers: 2055-06/07
PD Dr. med. Angelika Reißig
Phone: 00493641/ 9-32 41 28
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: August 15, 2011
Last Verified: August 2011

Keywords provided by University of Jena:
chest ultrasound
Sensitivity and specificity of chest ultrasound in diagnosing pneumonia

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections