Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-29 @ 7:12 PM
Study NCT ID:
NCT03943732
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2019-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Measuring the Clinical Impact of the FilmArray® Pneumonia Panel in Critically Ill
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Open Randomized study, consecutive 2 weeks-period for observation group and study group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2019-05-08', 'studyFirstSubmitQcDate': '2019-05-08', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Turn Around Time Treatment', 'timeFrame': '48 hours from arrival of the respiratory sample at the laboratory', 'description': 'Turn Around Time administration of optimal antimicrobial treatment'}], 'secondaryOutcomes': [{'measure': 'Performances FilmArray Pneumonia', 'timeFrame': '1 week from arrival of the respiratory sample at the laboratory', 'description': 'Microbiological performances FA-PNEU test versus routine microbiology testing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pneumonia', 'Molecular Testing', 'Clinical impact', 'FilmArray Pneumonia'], 'conditions': ['Pneumonia']}, 'referencesModule': {'references': [{'pmid': '33395094', 'type': 'DERIVED', 'citation': 'Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to measure how the use of Film-Array Pneumonia (FA-PNEU) on respiratory samples of adult patients suspected of acute care pneumonia in the intensive care unit of Saint-Luc University Hospital can accelerate / improve the initiation of the optimal antibiotic treatment.', 'detailedDescription': 'The main objective of this trial is to confirm/attest/prove the following statement:\n\nThe use of the FilmArray Pneumonia panel on respiratory samples of critically ill suspected with pneumonia, enables a faster microbiological pneumonia diagnosis and an improved therapeutic management of the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients 18 years, remaining at the intensive care of the Saint-Luc University Hospital\n* Recently transferred from emergency care with Community acquired Pneumonia of grade 4 suspicion\n* With a Ventilation acquired Pneumonia suspicion\n\nSuspicion will be based on symptoms, clinical, biological and radiological criteria.\n\nExclusion Criteria:\n\n* Patients from whom no respiratory sample can be obtained\n* Patients benefitting from palliative care\n* Insufficient volume of the respiratory sample after routine testing to perform the FA-PNEU test.'}, 'identificationModule': {'nctId': 'NCT03943732', 'acronym': 'FA-PNEU', 'briefTitle': 'Trial Measuring the Clinical Impact of the FilmArray® Pneumonia Panel in Critically Ill', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Randomized Trial Measuring the Clinical Impact of the FilmArray® Pneumonia, a Prospective Interventional Trial', 'orgStudyIdInfo': {'id': 'FA-PNEU'}, 'secondaryIdInfos': [{'id': '2019/14MAR/124', 'type': 'OTHER', 'domain': 'CEHF'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Respiratory samples are treated according to routine laboratory testing : culture, immuno assays'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Respiratory samples are treated according to routine laboratory testing : culture, immuno assays AND molecular testing (FilmArray PNEU) of the endotracheal aspirate sample 24 hours a day.', 'interventionNames': ['Diagnostic Test: FilmArray Pneumonia']}], 'interventions': [{'name': 'FilmArray Pneumonia', 'type': 'DIAGNOSTIC_TEST', 'description': 'FilmArray Pneumonia testing of tracheal sample', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Alexia VERROKEN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires St-Luc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioMérieux', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}