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

NCT04210102 | Active Not Recruiting

• 1 other identifier: 17-14
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

CR + LUS

OTHER

Patient will be performed first the Chest radiography then the Lung ultrasound.

Diagnostic Test: Lung Ultrasound (LUS); Diagnostic Test: Chest radiography (CR)

LUS + CR

OTHER

Patient will be performed first the Lung ultrasound then the Chest radiography

Diagnostic Test: Lung Ultrasound (LUS); Diagnostic Test: Chest radiography (CR)

Interventions

Lung Ultrasound (LUS) DIAGNOSTIC_TEST

Lung Ultrasound : Ultrasound is a medical imaging technique that relies on the use of ultrasound, inaudible sound waves, which allow to "visualize" lungs.

CR + LUS; LUS + CR

Chest radiography (CR) DIAGNOSTIC_TEST

The chest X-ray is a medical imaging examination that provides images of the lungs through the X-ray pulse.

CR + LUS; LUS + CR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead
• Centre Hospitalier Princesse Grace: collaborator

Study Sites (1)

CHPG

Monaco, Monaco

Location

Related Publications (3)

• 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.

  PMID: 8866576 BACKGROUND

• 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.

  PMID: 12168744 BACKGROUND

• 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.

  PMID: 26168322 BACKGROUND

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• CLAESSENS Yann-Erick, MD, PhD

  CH Princesse Grâce

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective and randomised study in 2 parallel groups to compare diagnosis performance of LUS and CR as a primary imaging for diagnosis of CAP

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 24, 2019
• Study Start: February 11, 2020
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)