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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03411824
Other study ID # RC16_0439
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 8, 2016
Est. completion date February 8, 2019

Study information

Verified date March 2021
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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 .


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 )


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date February 8, 2019
Est. primary completion date February 8, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria : - clinical suspicion of PAC Exclusion Criteria : - documented end-of-life - pregnancy - seriously ill patients

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
Non applicable

Locations

Country Name City State
France La Roche Sur Yon Hospital La Roche-sur-Yon
France Nantes University Hospital Nantes
France Poitiers University Hospital Poitiers
France Saint-Nazaire Hospital Saint-Nazaire

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Concordancy of CAP classification diagnosis concordancy ( after LUS) compared to adjudication committee CAP classification (definite, probable, possible, excluded) and kappa coefficient. 28 days after enrollment
Secondary Frequency of Antibiotic prescription modification after LUS 95% confidence interval of antibiotic prescription intention frequency Day 0
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