- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05140408
Efficiency of the Imaging Strategy for the Management of Pneumonia (EFFI-PNEUMO)
December 22, 2021 updated by: University Hospital, Strasbourg, France
Efficiency of the Imaging Strategy for the Management of Pneumonia in the Emergency Department
For patients with suspected pneumonia presenting to the emergency room, the imaging strategy most often involves a frontal and lateral chest x-ray despite poor diagnostic input.
Indeed, the radiography is not very sensitive and specific for the diagnosis of pneumopathy compared to the scanner.
However, the scanner remains the gold standard, the major constraint of which concerns the irradiation to which the patient is exposed.
The new scanners allow ultra-low-dose scans with better sensitivity than standard radiography with an equivalent dose of radiation.
In addition, the ultra-low-dose scanner helps prevent diagnostic errors and unintended treatments.
A low-dose CT scan for suspected pneumonia has been possible in the Strasbourg emergency department since March 2019.
The investigators therefore hypothesize that a diagnostic strategy involving the performance of a low dose CT scan in the event of suspicion of pneumopathy in the emergency room makes it possible to improve the adequacy of the diagnosis made by the initial imaging examination and the diagnosis on discharge from hospitalization, to reduce respiratory or hemodynamic complications and to reduce the prescription of antibiotic therapy that is not suitable for the patient.
course of the imaging result validated by a panel of emergency physicians and infectious disease specialists based on medical records in accordance with the recommendations.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
2240
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Strasbourg, France, 67091
- Recruiting
- Service d'accueil des urgences - Hôpitaux Universitaires de Strasbourg
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Sub-Investigator:
- Mickaël OHANA, MD, PhD
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Sub-Investigator:
- Yvon Ruch, MD
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Sub-Investigator:
- Isabelle Durand Zaleski, Statistician
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Sub-Investigator:
- Jérome Frenkiel, Statistician
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Sub-Investigator:
- Kevin Zarca, Statistician
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Major subject consulting the emergency department and had a final diagnosis of pneumonia
Description
Inclusion criteria:
- Major subject (≥18 years old)
- Emergency consultant subject with a final diagnosis of pneumonia, diagnostic code J18 and J15 with imaging: standard radiography or low dose scanner from 03/01/2019 to 02/29/2020
- Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research
Exclusion criteria:
- Subject having expressed opposition to participating in the study
- Absence of emergency imaging
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Study of the imaging strategy for the management of patients with pneumonia in emergency departments
Time Frame: Files analysed retrospectively from March 01, 2019 to February 29, 2020 will be examined]
|
Files analysed retrospectively from March 01, 2019 to February 29, 2020 will be examined]
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Anticipated)
January 31, 2022
Study Completion (Anticipated)
January 31, 2022
Study Registration Dates
First Submitted
October 13, 2021
First Submitted That Met QC Criteria
November 17, 2021
First Posted (Actual)
December 1, 2021
Study Record Updates
Last Update Posted (Actual)
January 12, 2022
Last Update Submitted That Met QC Criteria
December 22, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8129 (CTEP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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