Role of Chest Ultrasound in Diagnosing and Follow-up of P... | NCT00808457

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

NCT00808457

Sponsor

University of Jena

Status

Completed

Last Update Posted

Aug 15, 2011Estimated

Enrollment

397Actual

Phase

Not provided

Conditions

Pneumonia

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Dec 12, 2008

First Submission Date that Met QC Criteria

Dec 12, 2008

First Posted Date

Dec 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2011

Last Update Posted Date

Aug 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

397Actual

Label	Type	Description	Intervention Names
patients with suspected pneumonia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensitivity of chest ultrasound in diagnosing pneumonia		baseline diagnostic

Secondary Outcomes

Measure	Description	Time Frame
Specificity		baseline diagnostic

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with clinically suspected community-acquired pneumonia.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pneumology, Friedrich-Schiller University Jena		Jena	Thuringia	07740	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17337882	Background	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.
18386121	Background	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.

ID	Term
D011014	Pneumonia
D006967	Hypersensitivity

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Type	Description	Link
PD Dr. med. Angelika Reißig
Phone: 00493641/ 9-32 41 28