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NCT Number: NCT04210102

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHPG

Monaco

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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

    Time frame: Within the day of inclusion

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Collaborators

  • Centre Hospitalier Princesse Grace

Registry information

Official study title

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

Acronym: CAPUERA

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Dec 24, 2019
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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