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CompletedNCT03411824ECHOPACUpdated Mar 19, 2021

Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine

An observational study in Community Acquired Pneumonia, sponsored by Nantes University Hospital. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-19.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 40 studies in Community-Acquired Pneumonia with a site in France — 11 open to participants now, 11 under way, 5 of them phase 3. Community-Acquired Pneumonia · France.

Enrollment
13th of 14
90 · median 365
Started
2016
with 2 others
Observational
14 of 40
2 open now
Registered
16th of 40
by date
Lead sponsor
3 of 40
Nantes University Hospital

Among the 40 studies in Community-Acquired Pneumonia with a site in France, this one is the 13th largest by enrollment of the 14 observational ones, is one of 3 that started in 2016, is one of 14 observational ones, and was the 16th registered.

By phase

40 studies; the count open now beside each. This study's row is marked.

Observationalthis study14 · 2 open
No phase11 · 3 open
Phase 39 · 5 open
Phase 24 · 0 open
Phase 42 · 1 open

By the year they started

First in 2004; this study’s year is marked. 3 started in 2016.

Size and results

Median enrollment 327 across the 26 interventional studies, 365 across the 14 observational. Of the 27 that completed or were terminated, 2 (7%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 40 studies in Community-Acquired Pneumonia with a site in France, or all of them as a file.
02

Study 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.

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 .

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 )

03

Conditions studied

  • Community Acquired Pneumonia

Keywords

  • diagnosis
  • Point-of-Care-Ultrasound
  • lung ultrasound
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • clinical suspicion of PAC

Exclusion criteria

Exclusion Criteria :

  • documented end-of-life
  • pregnancy
  • seriously ill patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Interventions

  • Otherno intervention

    Non applicable

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 0

Secondary outcomes

  1. Concordancy of CAP classification diagnosis concordancy ( after LUS) compared to adjudication committee

    CAP classification (definite, probable, possible, excluded) and kappa coefficient.

    Time frame: 28 days after enrollment

  2. Frequency of Antibiotic prescription modification after LUS

    95% confidence interval of antibiotic prescription intention frequency

    Time frame: Day 0

07

Study locations

4 sites
  • La Roche Sur Yon Hospital
    La Roche-sur-Yon, 85925, France
  • Nantes University Hospital
    Nantes, 44093, France
  • Poitiers University Hospital
    Poitiers, 86000, France
  • Saint-Nazaire Hospital
    Saint-Nazaire, 44606, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2016 to primary completion in Feb 2019, 27 months.

Of 38 observational studies under Community-Acquired Pneumonia, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 57. This study's 27 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2017
First posted
Jan 26, 2018
StartActual
Nov 8, 2016
Primary completionActual
Feb 8, 2019
CompletionActual
Feb 8, 2019
Last update
Mar 19, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03411824
Responsible party
Sponsor
First posted
Jan 26, 2018
Start date
Nov 8, 2016
Primary completion
Feb 8, 2019
Completion
Feb 8, 2019
Last update
Mar 19, 2021

Study contacts

Philippe Le Conte, Pr
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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