Community Acquired PneumoniaECHOPACNCT03411824
Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine
An observational study of Community Acquired Pneumonia, run by Nantes University Hospital at 4 sites in France.
Trial summary
Community-acquired pneumonia (CAP) is frequently suspected in the Emergency Department (ED). However, usual diagnosis procedure based on clinical features and chest X-Ray has rather bad performances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- How many people
- 90 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Nov 2016to 8 Feb 2019
- 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: 120 patients will be enrolled on CAP suspicion. All explorations (radiography…) and biological exams (blood culture…) will be performed as usual to build physician primary diagnosis. Complementarily, an EP will be realized and final diagnosis will be made by physician. Finally, at Day28 expert adjudication committee will authentify diagnosis considering explorations and clinical issues. Frequency of discordant diagnosis between 1st and 2nd assessment and against expert will be measured
Who may be able to join
- clinical suspicion of PAC
Who cannot join
- documented end-of-life
- pregnancy
- seriously ill patients
Trial locations and contacts
4 sites in 1 country.
France4 sites
La Roche Sur Yon Hospital
La Roche-sur-Yon, 85925
Nantes University Hospital
Nantes, 44093
Poitiers University Hospital
Poitiers, 86000
Saint-Nazaire Hospital
Saint-Nazaire, 44606
About this study
Community-acquired pneumonia (CAP) is frequently suspected in the Emergency Department (ED). However, usual diagnosis procedure based on clinical features and chest X-Ray has rather bad performances.
A recent study on CT performance in suspected CAP found that 58% of classifications were modified by CT when compared with usual procedure. However, extended CT usage in CAP diagnosis is associated with many limitations :
Read more
availability in a majority of ED, delay, cost and irradiation, in particular In young patients.
Lung Ultrasound (LUS) has good performances in CAP diagnosis even when compared with CT. It is a rapid, inexpensive, radiation-free tool available in a majority of ED. It is performed at the patient's bedside with immediate results. The learning curve allows Emergency Physicians (EP) to perform this exam after a relative brief training.
The Investigators aim to investigate LUS performances in clinically suspected CAP authentication , and assesses specific diagnostic contributions and impact on antibiotic prescriptions .
Read the detailed description
120 patients will be enrolled on CAP suspicion. All explorations (radiography…) and biological exams (blood culture…) will be performed as usual to build physician primary diagnosis. Complementarily, an EP will be realized and final diagnosis will be made by physician. Finally, at Day28 expert adjudication committee will authentic diagnosis considering explorations and clinical issues. Frequency of discordant diagnosis between 1st and 2nd assessment and against expert will be measured Primary Purpose: diagnostic Study Phase: Not Applicable Intervention Model: NA Number of Arms: 1 Masking: open label, Masked Roles: NA Allocation: NA Study Endpoint Classification: efficacy Enrollment: 120 subjects (anticipated )
- Conditions
- Community Acquired Pneumonia
- Being tested
- no intervention
- Keywords
- diagnosis, Point-of-Care-Ultrasound, lung ultrasound
- Medical subject headings
- Community-Acquired Pneumonia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Non applicable
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of PAC classification modification (definite, probable, possible, excluded) after LUS realization
95% confidence interval of CAP classification modification frequency before and after LUS realization
Measured: Day 0
Secondary outcomes (2)
Concordancy of CAP classification diagnosis concordancy ( after LUS) compared to adjudication committee
CAP classification (definite, probable, possible, excluded) and kappa coefficient.
Measured: 28 days after enrollment
Frequency of Antibiotic prescription modification after LUS
95% confidence interval of antibiotic prescription intention frequency
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start8 Nov 2016
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Le Conte, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411824
- Sponsor's protocol ID
- RC16_0439
- Acronym
- ECHOPAC
- Status last verified
- Mar 2021
- First submitted
- 30 Nov 2017
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Javaudin F, Marjanovic N, de Carvalho H, Gaborit B, Le Bastard Q, Boucher E, Haroche D, Montassier E, Le Conte P. Contribution of lung ultrasound in diagnosis of community-acquired pneumonia in the emergency department: a prospective multicentre study. BMJ Open. 2021 Sep 24;11(9):e046849. doi: 10.1136/bmjopen-2020-046849.
PubMed 34561254
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine
- ClinicalTrials.gov ID
- NCT03411824
- Acronym / sponsor ID
- ECHOPAC / RC16_0439
- Conditions
- Community Acquired Pneumonia
- Keywords
- diagnosis, Point-of-Care-Ultrasound, lung ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 26 Jan 2018 (actual)
- 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.
Community-acquired pneumonia (CAP) is frequently suspected in the Emergency Department (ED). However, usual diagnosis procedure based on clinical features and chest X-Ray has rather bad performances.
A recent study on CT performance in suspected CAP found that 58% of classifications were modified by CT when compared with usual procedure. However, extended CT usage in CAP diagnosis is associated with many limitations :
availability in a majority of ED, delay, cost and irradiation, in particular In young patients.
Lung Ultrasound (LUS) has good performances in CAP diagnosis even when compared with CT. It is a rapid, inexpensive, radiation-free tool available in a majority of ED. It is performed at the patient's bedside with immediate results. The learning curve allows Emergency Physicians (EP) to perform this exam after a relative brief training.
The Investigators aim to investigate LUS performances in clinically suspected CAP authentication , and assesses specific diagnostic contributions and impact on antibiotic prescriptions .
Detailed description
120 patients will be enrolled on CAP suspicion. All explorations (radiography…) and biological exams (blood culture…) will be performed as usual to build physician primary diagnosis. Complementarily, an EP will be realized and final diagnosis will be made by physician. Finally, at Day28 expert adjudication committee will authentic diagnosis considering explorations and clinical issues. Frequency of discordant diagnosis between 1st and 2nd assessment and against expert will be measured Primary Purpose: diagnostic Study Phase: Not Applicable Intervention Model: NA Number of Arms: 1 Masking: open label, Masked Roles: NA Allocation: NA Study Endpoint Classification: efficacy Enrollment: 120 subjects (anticipated )
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120 patients will be enrolled on CAP suspicion. All explorations (radiography…) and biological exams (blood culture…) will be performed as usual to build physician primary diagnosis. Complementarily, an EP will be realized and final diagnosis will be made by physician. Finally, at Day28 expert adjudication committee will authentify diagnosis considering explorations and clinical issues. Frequency of discordant diagnosis between 1st and 2nd assessment and against expert will be measured
Key inclusion criteria (1 listed)
- clinical suspicion of PAC
Key exclusion criteria (3 listed)
- documented end-of-life
- pregnancy
- seriously ill patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionNon applicable | Other | – |
Primary outcome
Frequency of PAC classification modification (definite, probable, possible, excluded) after LUS realization
Time frame: Day 0
95% confidence interval of CAP classification modification frequency before and after LUS realization
2 secondary outcomes
Concordancy of CAP classification diagnosis concordancy ( after LUS) compared to adjudication committee
Time frame: 28 days after enrollment
Frequency of Antibiotic prescription modification after LUS
Time frame: Day 0
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 19 Mar 2021.
- Derived from this study: PubMed 34561254Javaudin F, Marjanovic N, de Carvalho H, Gaborit B, Le Bastard Q, Boucher E, Haroche D, Montassier E, Le Conte P. Contribution of lung ultrasound in diagnosis of community-acquired pneumonia in the emergency department: a prospective multicentre study. BMJ Open. 2021 Sep 24;11(9):e046849. doi: 10.1136/bmjopen-2020-046849.
- Individual participant dataSharing planned: No
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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.
Philippe Le Conte, Pr principal investigator
Nantes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Acquired Pneumonia, run by Nantes University Hospital at 4 sites in France.
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 1 inclusion and 3 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 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Frequency of PAC classification modification (definite, probable, possible, excluded) after LUS realization (time frame: Day 0). 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 NCT03411824, which also lists 1 linked publication.
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 19 Mar 2021.