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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
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Community-acquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 11, 2019
    Last Updated
    February 7, 2020
    Sponsor
    Centre Hospitalier Universitaire de Nice
    Collaborators
    Centre Hospitalier Princesse Grace
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    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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