Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-02 @ 4:00 AM
Study NCT ID:
NCT00808457
Status:
COMPLETED
Last Update Posted:
2011-08-15
First Post:
2008-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Chest Ultrasound in Diagnosing and Follow-up of Pneumonia
Sponsor:
University of Jena
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
• 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: