PneumoniaNCT00808457
Role of Chest Ultrasound in Diagnosing and Follow-up of Pneumonia
An observational study of Pneumonia, run by University of Jena at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- How many people
- 397 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinically suspected community-acquired pneumonia.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Pneumology, Friedrich-Schiller University Jena
Jena, Thuringia, 07740
About this study
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
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.
Read the 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.
- Conditions
- Pneumonia
- Keywords
- chest ultrasound, pneumonia, X-ray, CT, Sensitivity and specificity of chest ultrasound in diagnosing pneumonia
- Medical subject headings
- Pneumonia, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with suspected pneumonia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of chest ultrasound in diagnosing pneumonia
Measured: baseline diagnostic
Secondary outcomes (1)
Specificity
Measured: baseline diagnostic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808457
- Sponsor's protocol ID
- 2055-06/07
- Other IDs
- PD Dr. med. Angelika Reißig, Phone: 00493641/ 9-32 41 28
- Status last verified
- Aug 2011
- First submitted
- 12 Dec 2008
- Last updated
- 15 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17337882Copetti 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.
PubMed 18386121Reissig 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.
PubMed 23564195Reissig 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.
PubMed 22700780
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00808457
- Acronym / sponsor ID
- 2055-06/07
- Conditions
- Pneumonia
- Keywords
- chest ultrasound, pneumonia, X-ray, CT, Sensitivity and specificity of chest ultrasound in diagnosing pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with suspected pneumonia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically suspected community-acquired pneumonia.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sensitivity of chest ultrasound in diagnosing pneumonia
Time frame: baseline diagnostic
1 secondary outcome
Specificity
Time frame: baseline diagnostic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2011.
- Background: PubMed 17337882Reissig 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.
- Background: PubMed 18386121Copetti 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.
- Derived from this study: PubMed 23564195Reissig 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.
- Derived from this study: PubMed 22700780Reissig 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.
Related trials for Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of chest ultrasound in diagnosing pneumonia (time frame: baseline diagnostic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00808457, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2011.