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Community-acquired PneumoniaCAPUERANCT04210102

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

A study testing Lung Ultrasound (LUS) and Chest radiography (CR) in people with Community-acquired Pneumonia, run by Centre Hospitalier Universitaire de Nice at 1 site in Monaco.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Community-acquired Pneumonia
What is being tested?
Lung Ultrasound (LUS) and Chest radiography (CR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteMonaco
Study dates
11 Feb 2020to 28 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Monaco1 site

  • CHPG

    Monaco

Other trials in Monaco

About this study

Official title: 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.

Being tested
Lung Ultrasound (LUS), Chest radiography (CR)
Medical subject headings
Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04210102
Study groupRoleWhat they receive
CR + LUSOtherPatient will be performed first the Chest radiography then the Lung ultrasound.
Receives: Diagnostic Test: Lung Ultrasound (LUS); Diagnostic Test: Chest radiography (CR)
LUS + CROtherPatient will be performed first the Lung ultrasound then the Chest radiography
Receives: Diagnostic Test: Lung Ultrasound (LUS); Diagnostic Test: Chest radiography (CR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Within the day of inclusion

Secondary outcomes (4)

  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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2019
  2. Study start11 Feb 2020
  3. Primary completion28 Jan 2025
  4. Study completion28 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04210102
Sponsor's protocol ID
17-14
Acronym
CAPUERA
Status last verified
Mar 2025
First submitted
11 Dec 2019
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 8866576

  • 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.

    PubMed 12168744

  • 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.

    PubMed 26168322

Questions about this trial

What is this clinical trial studying?

A study testing Lung Ultrasound (LUS) and Chest radiography (CR) in people with Community-acquired Pneumonia, run by Centre Hospitalier Universitaire de Nice at 1 site in Monaco.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04210102, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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