Efficiency of the Imaging Strategy for the Management of... | NCT05140408

Studies
Efficiency of the Imaging Strategy for the Management of Pneumonia

NCT05140408

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jan 12, 2022Actual

Enrollment

2,240Estimated

Phase

Not provided

Conditions

Pneumonia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Actual

Primary Completion Date

Jan 31, 2022Estimated

Completion Date

Jan 31, 2022Estimated

First Submitted Date

Oct 13, 2021

First Submission Date that Met QC Criteria

Nov 17, 2021

First Posted Date

Dec 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2021

Last Update Posted Date

Jan 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,240Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Study of the imaging strategy for the management of patients with pneumonia in emergency departments		Files analysed retrospectively from March 01, 2019 to February 29, 2020 will be examined]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Major subject consulting the emergency department and had a final diagnosis of pneumonia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sabrina GARNIER KEPKA, MD	Contact	33 3 69 55 13 35		Sabrina.GARNIER-KEPKA@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR	Contact			said.chayer@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Accueil des Urgences - Hôpitaux Universitaires de Strasbourg	Recruiting	Strasbourg		67091	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40392398	Derived	Kepka S, Zarca K, Ohana M, Hoffbeck L, Heimann C, Borgne PL, Severac F, Muller J, Sauleau EA, Bilbault P, Zaleski ID. Cost effectiveness of imaging strategies in the emergency department for the diagnostic workup of community-acquired pneumonia: a real-life retrospective study. Health Econ Rev. 2025 May 20;15(1):41. doi: 10.1186/s13561-025-00625-8.

ID	Term
D011014	Pneumonia
D004630	Emergencies
D008171	Lung Diseases

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D012140	Respiratory Tract Diseases
D020969	Disease Attributes