Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT04210102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2019-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Community-Acquired Pneumonia Diagnosis Using Lung Ultrasound in Emergency Room Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective and randomised study in 2 parallel groups to compare diagnosis performance of LUS and CR as a primary imaging for diagnosis of CAP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2019-12-11', 'studyFirstSubmitQcDate': '2019-12-20', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Within the day of inclusion'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'Within the day of inclusion'}, {'measure': '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', 'timeFrame': 'Within the day of inclusion'}, {'measure': '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', 'timeFrame': 'Up to 6 months'}, {'measure': 'The concordance of interpretation (for CR and CT) between attending radiologist and expert radiologist of the adjudication committee (gold standard) wil be studied.', 'timeFrame': 'Up to 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Community-acquired Pneumonia']}, 'referencesModule': {'references': [{'pmid': '8866576', 'type': 'BACKGROUND', 'citation': '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': '12168744', 'type': 'BACKGROUND', 'citation': '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': '26168322', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18+)\n* Suspected CAP by attending emergency physician\n* And new onset of systemic infection (at least one among sweat, chills, aches and pain, temperature ≥38°C or \\<36°C)\n* And symptoms of an acute lower respiratory tract infection (at least one among cough, sputum production, dyspnea, chest pain, altered breathing sounds at auscultation\n* No previous imaging for the current medical problem\n* Inform consent (signed)\n* Affiliation to insurance (France, Monaco)\n\nExclusion Criteria:\n\n* Age below 18-year of age\n* Patients in palliative care\n* Pregnant women\n* anticipated barriers to completing follow-up data collection,\n* patients classified three or higher according to the CRB65 score,\n* patients requiring intensive care for any purpose because of specific management of critically ill\n* refusal to participate to the study'}, 'identificationModule': {'nctId': 'NCT04210102', 'acronym': 'CAPUERA', 'briefTitle': 'Community-Acquired Pneumonia Diagnosis Using Lung Ultrasound in Emergency Room Adults', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Accuracy of Lung Ultrasound for the Diagnosis of Community-Acquired Pneumonia in Emergency Room Patients', 'orgStudyIdInfo': {'id': '17-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CR + LUS', 'description': 'Patient will be performed first the Chest radiography then the Lung ultrasound.', 'interventionNames': ['Diagnostic Test: Lung Ultrasound (LUS)', 'Diagnostic Test: Chest radiography (CR)']}, {'type': 'OTHER', 'label': 'LUS + CR', 'description': 'Patient will be performed first the Lung ultrasound then the Chest radiography', 'interventionNames': ['Diagnostic Test: Lung Ultrasound (LUS)', 'Diagnostic Test: Chest radiography (CR)']}], 'interventions': [{'name': 'Lung Ultrasound (LUS)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lung Ultrasound : Ultrasound is a medical imaging technique that relies on the use of ultrasound, inaudible sound waves, which allow to "visualize" lungs.', 'armGroupLabels': ['CR + LUS', 'LUS + CR']}, {'name': 'Chest radiography (CR)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The chest X-ray is a medical imaging examination that provides images of the lungs through the X-ray pulse.', 'armGroupLabels': ['CR + LUS', 'LUS + CR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Monaco', 'country': 'Monaco', 'facility': 'CHPG', 'geoPoint': {'lat': 43.73718, 'lon': 7.42145}}], 'overallOfficials': [{'name': 'CLAESSENS Yann-Erick, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Princesse Grâce'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Princesse Grace', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}