Community-Acquired Pneumonia Diagnosis Using Lung Ultrasound in Emergency Room Adults (CAPUERA)

Accuracy of Lung Ultrasound for the Diagnosis of Community-Acquired Pneumonia in Emergency Room Patients

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.

Study Overview

• Status: Unknown
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Diagnostic test: Lung Ultrasound (LUS); Diagnostic test: Chest radiography (CR)

• Study Type: Interventional
• Enrollment (Anticipated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CLAESSENS Yann-Erick, MD, PhD; Phone Number: +377 97 98 84 42; Email: yann-erick.claessens@chpg.mc
• Study Contact Backup: Name: LABIT Melody; Phone Number: +377 97 98 84 42; Email: recherche.clinique@chpg.mc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: CR + LUS; Patient will be performed first the Chest radiography then the Lung ultrasound.	Diagnostic test: Lung Ultrasound (LUS); Lung Ultrasound : Ultrasound is a medical imaging technique that relies on the use of ultrasound, inaudible sound waves, which allow to "visualize" lungs.; Diagnostic test: Chest radiography (CR); The chest X-ray is a medical imaging examination that provides images of the lungs through the X-ray pulse.
OTHER: LUS + CR; Patient will be performed first the Lung ultrasound then the Chest radiography	Diagnostic test: Lung Ultrasound (LUS); Lung Ultrasound : Ultrasound is a medical imaging technique that relies on the use of ultrasound, inaudible sound waves, which allow to "visualize" lungs.; Diagnostic test: Chest radiography (CR); The chest X-ray is a medical imaging examination that provides images of the lungs through the X-ray pulse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Within the day of inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Within the day of inclusion
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	Within the day of inclusion
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	Up to 6 months
The concordance of interpretation (for CR and CT) between attending radiologist and expert radiologist of the adjudication committee (gold standard) wil be studied.	Up to 6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Collaborators: Centre Hospitalier Princesse Grace
• Investigators: Principal Investigator: CLAESSENS Yann-Erick, MD, PhD, CH Princesse Grace

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 15, 2020
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (ACTUAL): December 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Emergencies; Pneumonia
• Other Study ID Numbers: 17-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No