NCT03411824

Brief 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 .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

4 active sites

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

November 8, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2019

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

2.3 years

First QC Date

November 30, 2017

Last Update Submit

March 18, 2021

Conditions

Community Acquired Pneumonia

Keywords

diagnosisPoint-of-Care-Ultrasoundlung ultrasound

Outcome Measures

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

    Day 0

Secondary Outcomes (2)

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

    28 days after enrollment

  • Frequency of Antibiotic prescription modification after LUS

    Day 0

Interventions

no interventionOTHER

Non applicable

Eligibility Criteria

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

You may qualify if:

  • \- clinical suspicion of PAC

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

La Roche Sur Yon Hospital

La Roche-sur-Yon, 85925, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Poitiers University Hospital

Poitiers, 86000, France

Location

Saint-Nazaire Hospital

Saint-Nazaire, 44606, France

Location

Related Publications (1)

  • 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.

    PMID: 34561254DERIVED

MeSH Terms

Conditions

Community-Acquired PneumoniaDisease

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Philippe Le Conte, Pr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

January 26, 2018

Study Start

November 8, 2016

Primary Completion

February 8, 2019

Study Completion

February 8, 2019

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)