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

This study has been completed.
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT00808457
First received: December 12, 2008
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

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
Pneumonia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • sensitivity of chest ultrasound in diagnosing pneumonia [ Time Frame: baseline diagnostic ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Specificity [ Time Frame: baseline diagnostic ] [ Designated as safety issue: No ]

Enrollment: 397
Study Start Date: September 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with suspected pneumonia

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with clinically suspected community-acquired pneumonia.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808457

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

Publications:
Additional 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
Study First Received: December 12, 2008
Last Updated: August 12, 2011
Health Authority: Germany: Ethics Commission
Austria: Ethikkommission

Keywords provided by University of Jena:
chest ultrasound
pneumonia
X-ray
CT
Sensitivity and specificity of chest ultrasound in diagnosing pneumonia

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

ClinicalTrials.gov processed this record on August 28, 2014