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

NCT ID: NCT04210102

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-11
• Study Completion Date: 2026-01-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CR + LUS

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

Group Type: OTHER

Lung Ultrasound (LUS)

Intervention Type: 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.

Chest radiography (CR)

Intervention Type: DIAGNOSTIC_TEST

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

LUS + CR

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

Group Type: OTHER

Lung Ultrasound (LUS)

Intervention Type: 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.

Chest radiography (CR)

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Princesse Grace

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CLAESSENS Yann-Erick, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CH Princesse Grâce

Locations

CHPG

Monaco, , Monaco

Countries

Monaco

References

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.

Reference Type: BACKGROUND

PMID: 8866576 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12168744 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26168322 (View on PubMed)

Other Identifiers

17-14

Identifier Type: -

Identifier Source: org_study_id