Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-26 @ 6:15 PM
Study NCT ID:
NCT06428318
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Value of the Biofire®in Community Acquired Pneumonia
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-26', 'studyFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-05-21', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the ICU length of stay', 'timeFrame': 'Five days after admission', 'description': 'The potential correlation between the use of BFPP and its relation to the ICU length of stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'This study aimed to determine the impact value of the BioFire FilmArray Pneumonia panel compared to conventional sputum culture in critically ill patients with pneumonia.', 'detailedDescription': 'the BioFire® FilmArray Pneumonia Panel (BFPP) emerges as a promising candidate for a rapid and multifaceted diagnostic approach.\n\nThis study compare the diagnostic accuracy, turnaround time, and impact on antibiotic management decisions of BFPP versus conventional sputum culture in critically ill patients admitted to the ICU with suspected pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the ICU with community acquired pneumonia\n\nExclusion Criteria:\n\n* Age less than 18 years old.\n* End stage malignant patients,\n* Patients admitted to the ICU with Acute Lung Injury (ALI).\n* Patients admitted to the ICU with Acute Respiratory Distress Syndrome (ARDS).\n* Patients with radiological findings suggesting atypical pneumonia.\n* Immunocompromised as defined by HIV/AIDS, known immunodeficiency, chronic steroids \\> 20mg/day Prednisone equivalent, other immunosuppressants.\n* Solid organ or bone marrow transplant patients, cystic fibrosis.\n* Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete the study requirements.'}, 'identificationModule': {'nctId': 'NCT06428318', 'briefTitle': 'Diagnostic Value of the Biofire®in Community Acquired Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Diagnostic Value of the Biofire® Filmarray Pneumonia Panel Compared to Conventional Sputum Culture in Critically il Patients With Pneumonia', 'orgStudyIdInfo': {'id': 'FMASU MS267/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Routine Conventional Methods', 'description': 'Patients subjected to Routine sputum culture Conventional Methods', 'interventionNames': ['Diagnostic Test: Conventional Sputum culture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GroupB: BioFire Pneumonia Panel (BFPP).', 'description': 'Patients subjected to BioFire Pneumonia Panel (BFPP', 'interventionNames': ['Diagnostic Test: BioFire Pneumonia Panel (BFPP)']}], 'interventions': [{'name': 'Conventional Sputum culture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Sputum culture was done to patients and they received Antibiotics According to its results', 'armGroupLabels': ['Group A: Routine Conventional Methods']}, {'name': 'BioFire Pneumonia Panel (BFPP)', 'type': 'DIAGNOSTIC_TEST', 'description': 'BioFire Pneumonia Panel (BFPP) was done to patients and they received Antibiotics According to its results', 'armGroupLabels': ['GroupB: BioFire Pneumonia Panel (BFPP).']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Abassia', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rania Maher Hussien, MD', 'investigatorAffiliation': 'Ain Shams University'}}}}