Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT07140003
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-24
First Post:
2025-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pleural Tissue Culture Versus Pleural Fluid Culture in Infected Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'MICROBIOLOGICAL VALUE OF SONOGRAPHIC GUIDED PLEURAL TISSUE CULTURE PLUS PLEURAL FLUID CULTURE IN PATIENTS WITH INFECTED PLEURAL FLUID'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'initial pleural fluid and parietal pleural tissue', 'timeFrame': '2 weeks', 'description': 'the result of culture'}, {'measure': 'result of culture', 'timeFrame': 'one month', 'description': 'the result of pleural fluid culture and the pleural tissue culture result'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pleural tissue culture ,infected pleural fluid'], 'conditions': ['Pleural Tissue Culture']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/21793988/', 'label': 'national library of information'}]}, 'descriptionModule': {'briefSummary': 'comparison between the result of fluid culture and that of pleural tissue culture', 'detailedDescription': 'MICROBIOLOGICAL VALUE OF SONOGRAPHIC GUIDED PLEURAL TISSUE CULTURE PLUS PLEURAL FLUID CULTURE IN PATIENTS WITH INFECTED PLEURAL FLUID'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Exudate neutrophilic pleural fluid aspirate, or met at least one or more of the following criteria: grossly frank purulent, gram stain positive for bacteria, bacterial culture positive, acidic with a pH \\<7.20, low pleural fluid glucose (\\<55mg/dL), and CT evidence of pleural infection. Exclusion criteria: Pleural infections by Mycobacterium tuberculosis.Malignant effusion.Coagulation defects.'}, 'identificationModule': {'nctId': 'NCT07140003', 'briefTitle': 'Pleural Tissue Culture Versus Pleural Fluid Culture in Infected Effusion', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Microbiological Value of Sonographic Guided Pleural Tissue Culture Plus Pleural Fluid Culture in Patients With Infected Pleural Fluid', 'orgStudyIdInfo': {'id': 'pleura,tissue culture,sonograp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'one group of patients will undergo pleural fluid culture taken by ultrasound chest by 18 gauge needl', 'description': 'microbiological culture of the fluid', 'interventionNames': ['Procedure: pleural biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sonographic guided pleural tissue culture', 'description': 'pareital pleural biobsy will be taken from the posterior costal pleura by ultrasound via true cut biopsy 12 french and tissue will be sent to the micro alab', 'interventionNames': ['Procedure: pleural biopsy']}], 'interventions': [{'name': 'pleural biopsy', 'type': 'PROCEDURE', 'description': 'To assess whether pleural tissue culture can improve the identification of causative organisms in pleural infections (using the pleural fluid culture), which can aid in selecting appropriate antimicrobial therapy and improve treatment outcomes, thus may provide valuable insights into the utility of pleural tissue culture in managing pleural infection and may guide clinicians in selecting the most appropriate diagnostic approach.', 'armGroupLabels': ['one group of patients will undergo pleural fluid culture taken by ultrasound chest by 18 gauge needl', 'sonographic guided pleural tissue culture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11511', 'city': 'Alexandria', 'state': 'Chest Department', 'country': 'Egypt', 'facility': 'Chest Department -Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'mohamed sabry eltarhony, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}, {'name': 'hatem essam hamed, lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'according to the policy of ethics committee'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}