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

NCT ID: NCT00808457

Last Updated: 2011-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

397 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pneumonia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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patients with suspected pneumonia

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jena

OTHER

Sponsor Role lead

Responsible Party

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Pneumology, Friedrich-Schiller University Jena

Locations

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Pneumology, Friedrich-Schiller University Jena

Jena, Thuringia, Germany

Site Status

Countries

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Germany

References

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Reissig A, Kroegel C. Sonographic diagnosis and follow-up of pneumonia: a prospective study. Respiration. 2007;74(5):537-47. doi: 10.1159/000100427. Epub 2007 Feb 27.

Reference Type BACKGROUND
PMID: 17337882 (View on PubMed)

Copetti R, Cattarossi L. Ultrasound diagnosis of pneumonia in children. Radiol Med. 2008 Mar;113(2):190-8. doi: 10.1007/s11547-008-0247-8. Epub 2008 Apr 2. English, Italian.

Reference Type BACKGROUND
PMID: 18386121 (View on PubMed)

Reissig A, Mempel C, Schumacher U, Copetti R, Gross F, Aliberti S. Microbiological diagnosis and antibiotic therapy in patients with community-acquired pneumonia and acute COPD exacerbation in daily clinical practice: comparison to current guidelines. Lung. 2013 Jun;191(3):239-46. doi: 10.1007/s00408-013-9460-x. Epub 2013 Apr 6.

Reference Type DERIVED
PMID: 23564195 (View on PubMed)

Reissig A, Copetti R, Mathis G, Mempel C, Schuler A, Zechner P, Aliberti S, Neumann R, Kroegel C, Hoyer H. Lung ultrasound in the diagnosis and follow-up of community-acquired pneumonia: a prospective, multicenter, diagnostic accuracy study. Chest. 2012 Oct;142(4):965-972. doi: 10.1378/chest.12-0364.

Reference Type DERIVED
PMID: 22700780 (View on PubMed)

Other Identifiers

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PD Dr. med. Angelika Reißig

Identifier Type: -

Identifier Source: secondary_id

Phone: 00493641/ 9-32 41 28

Identifier Type: -

Identifier Source: secondary_id

2055-06/07

Identifier Type: -

Identifier Source: org_study_id

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