Community-Acquired Pneumonia Diagnosis Using Lung Ultrasound in Emergency Room Adults (CAPUERA)
Primary Purpose
Community-acquired Pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lung Ultrasound (LUS)
Chest radiography (CR)
Sponsored by
About this trial
This is an interventional diagnostic trial for Community-acquired Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Adult patients (18+)
- Suspected CAP by attending emergency physician
- And new onset of systemic infection (at least one among sweat, chills, aches and pain, temperature ≥38°C or <36°C)
- And symptoms of an acute lower respiratory tract infection (at least one among cough, sputum production, dyspnea, chest pain, altered breathing sounds at auscultation
- No previous imaging for the current medical problem
- Inform consent (signed)
- Affiliation to insurance (France, Monaco)
Exclusion Criteria:
- Age below 18-year of age
- Patients in palliative care
- Pregnant women
- anticipated barriers to completing follow-up data collection,
- patients classified three or higher according to the CRB65 score,
- patients requiring intensive care for any purpose because of specific management of critically ill
- refusal to participate to the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
CR + LUS
LUS + CR
Arm Description
Patient will be performed first the Chest radiography then the Lung ultrasound.
Patient will be performed first the Lung ultrasound then the Chest radiography
Outcomes
Primary Outcome Measures
The sensitivity of lung ultrasound (LUS) and chest X-ray (CR) to detect community-acquired pneumonia (CAP) will be mesured and compared in patients visiting the emergency department for suspected CAP
Secondary Outcome Measures
specificity, positive predictive value and negative predictive value : indicators of diagnosis performance, will be measured and compared as a primary imaging for diagnosis of CAP
Specificity, positive predictive value, negative predictive value will be measured and compared in each sequence of imaging (CR + LUS and LUS + CR) for CAP detection
medical decisions for diagnosis of CAP after each step LUS then CR or CR then LUS and after low dose CT6scan (CT) will be compared to the medical decisions of the adjudication committee
The concordance of interpretation (for CR and CT) between attending radiologist and expert radiologist of the adjudication committee (gold standard) wil be studied.
Full Information
NCT ID
NCT04210102
First Posted
December 11, 2019
Last Updated
February 7, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Centre Hospitalier Princesse Grace
1. Study Identification
Unique Protocol Identification Number
NCT04210102
Brief Title
Community-Acquired Pneumonia Diagnosis Using Lung Ultrasound in Emergency Room Adults
Acronym
CAPUERA
Official Title
Accuracy of Lung Ultrasound for the Diagnosis of Community-Acquired Pneumonia in Emergency Room Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2020 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Centre Hospitalier Princesse Grace
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Community-Acquired Pneumonia (CAP) is a major problem in Emergency Department (ED). Diagnosis relies on combination of clinical symptoms and results of chest radiography (CR). Patients' management (treatment, support) depends on delay and quality of the diagnosis. However, signs and symptoms are highly aspecific and interpretation of CR is subject to frequent discrepancies. Then diagnosis of CAP may be uncertain; therefore, overdiagnosis is frequent and leads to over-use of antimicrobial therapy; missing diagnosis is also deleterious and delays adequate treatment including antibiotics. CT scan completes CR and helps clinician making properly diagnosis of CAP; obtaining CT in a 4-hour time-lapse allows better diagnosis and management as accurate as an independent expert adjudication committee does. However availability of CT as well as radiation interrogates on the benefit that Lung Ultrasounds (LUS) may have in diagnosis strategy of suspected CAP. LUS is a noninvasive easy-to-use device whose practice is widely endorsed worldwide by emergency medicine associations and societies. Additionally, previous studies advocate for the use of LUS for diagnosis of CAP in the ED. Therefore the Promotor developed a study to compare LUS and CR as a primary imaging for diagnosis of CAP at the ED.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective and randomised study in 2 parallel groups to compare diagnosis performance of LUS and CR as a primary imaging for diagnosis of CAP
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CR + LUS
Arm Type
Other
Arm Description
Patient will be performed first the Chest radiography then the Lung ultrasound.
Arm Title
LUS + CR
Arm Type
Other
Arm Description
Patient will be performed first the Lung ultrasound then the Chest radiography
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung Ultrasound (LUS)
Intervention Description
Lung Ultrasound : Ultrasound is a medical imaging technique that relies on the use of ultrasound, inaudible sound waves, which allow to "visualize" lungs.
Intervention Type
Diagnostic Test
Intervention Name(s)
Chest radiography (CR)
Intervention Description
The chest X-ray is a medical imaging examination that provides images of the lungs through the X-ray pulse.
Primary Outcome Measure Information:
Title
The sensitivity of lung ultrasound (LUS) and chest X-ray (CR) to detect community-acquired pneumonia (CAP) will be mesured and compared in patients visiting the emergency department for suspected CAP
Time Frame
Within the day of inclusion
Secondary Outcome Measure Information:
Title
specificity, positive predictive value and negative predictive value : indicators of diagnosis performance, will be measured and compared as a primary imaging for diagnosis of CAP
Time Frame
Within the day of inclusion
Title
Specificity, positive predictive value, negative predictive value will be measured and compared in each sequence of imaging (CR + LUS and LUS + CR) for CAP detection
Time Frame
Within the day of inclusion
Title
medical decisions for diagnosis of CAP after each step LUS then CR or CR then LUS and after low dose CT6scan (CT) will be compared to the medical decisions of the adjudication committee
Time Frame
Up to 6 months
Title
The concordance of interpretation (for CR and CT) between attending radiologist and expert radiologist of the adjudication committee (gold standard) wil be studied.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (18+)
Suspected CAP by attending emergency physician
And new onset of systemic infection (at least one among sweat, chills, aches and pain, temperature ≥38°C or <36°C)
And symptoms of an acute lower respiratory tract infection (at least one among cough, sputum production, dyspnea, chest pain, altered breathing sounds at auscultation
No previous imaging for the current medical problem
Inform consent (signed)
Affiliation to insurance (France, Monaco)
Exclusion Criteria:
Age below 18-year of age
Patients in palliative care
Pregnant women
anticipated barriers to completing follow-up data collection,
patients classified three or higher according to the CRB65 score,
patients requiring intensive care for any purpose because of specific management of critically ill
refusal to participate to the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CLAESSENS Yann-Erick, MD, PhD
Phone
+377 97 98 84 42
Email
yann-erick.claessens@chpg.mc
First Name & Middle Initial & Last Name or Official Title & Degree
LABIT Melody
Phone
+377 97 98 84 42
Email
recherche.clinique@chpg.mc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CLAESSENS Yann-Erick, MD, PhD
Organizational Affiliation
CH Princesse Grâce
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8866576
Citation
Dorca J, Torres A. Lower respiratory tract infections in the community: towards a more rational approach. Eur Respir J. 1996 Aug;9(8):1588-9. doi: 10.1183/09031936.96.09081588. No abstract available.
Results Reference
background
PubMed Identifier
12168744
Citation
Woodhead M. Community-acquired pneumonia in Europe: causative pathogens and resistance patterns. Eur Respir J Suppl. 2002 Jul;36:20s-27s. doi: 10.1183/09031936.02.00702002.
Results Reference
background
PubMed Identifier
26168322
Citation
Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.
Results Reference
background
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Community-Acquired Pneumonia Diagnosis Using Lung Ultrasound in Emergency Room Adults
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