NCT00808457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

August 15, 2011

Status Verified

August 1, 2011

Enrollment Period

3.4 years

First QC Date

December 12, 2008

Last Update Submit

August 12, 2011

Conditions

Keywords

chest ultrasoundpneumoniaX-rayCTSensitivity and specificity of chest ultrasound in diagnosing pneumonia

Outcome Measures

Primary Outcomes (1)

  • sensitivity of chest ultrasound in diagnosing pneumonia

    baseline diagnostic

Secondary Outcomes (1)

  • Specificity

    baseline diagnostic

Study Arms (1)

patients with suspected pneumonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with clinically suspected community-acquired pneumonia.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pneumology, Friedrich-Schiller University Jena

Jena, Thuringia, 07740, Germany

Location

Related Publications (4)

  • 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.

    PMID: 17337882BACKGROUND
  • 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.

    PMID: 18386121BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

PneumoniaHypersensitivity

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesImmune System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2008

First Posted

December 15, 2008

Study Start

September 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

August 15, 2011

Record last verified: 2011-08

Locations