Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-21 @ 12:41 PM
Study NCT ID:
NCT01862458
Status:
WITHDRAWN
Last Update Posted:
2016-01-28
First Post:
2013-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empyema Treated With tPA & DNAse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004653', 'term': 'Empyema'}], 'ancestors': [{'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'funding difficulty', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2013-05-17', 'studyFirstSubmitQcDate': '2013-05-22', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['empyema', 'tPA', 'dornase'], 'conditions': ['Empyema']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tPA.\n\nThe hypothesis, driven by a recent prospective trial, is that tPA may benefit from the addition of DNAse.\n\nThe primary outcome variable between the two techniques will be length of hospitalization after initiation of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients less than 18 years of age requiring an intervention for empyema by one of the following:\n\n* Septation or loculation seen on ultrasound or computed tomography or\n* Greater than 10,000 white blood cells identified on pleural tap\n\nExclusion Criteria:\n\n* Immunodeficiency process\n* Secondary diagnosis or condition that will keep them in the hospital beyond the empyema\n* Existing contraindications to chest tube\n* Documented allergy to one of the study medications'}, 'identificationModule': {'nctId': 'NCT01862458', 'briefTitle': 'Empyema Treated With tPA & DNAse', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Prospective Randomized Trial: Fibrinolysis With tPA (Tissue Plasminogen Activator) Versus tPA and DNAse in Children With Empyema', 'orgStudyIdInfo': {'id': '12120552'}, 'secondaryIdInfos': [{'id': '12120552', 'type': 'OTHER', 'domain': "Children's Mercy Hospital"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tPA alone', 'description': 'tPA alone used to treat empyema', 'interventionNames': ['Biological: tPA alone']}, {'type': 'EXPERIMENTAL', 'label': 'tPA plus dornase', 'description': 'tPA plus dornase used to treat empyema', 'interventionNames': ['Biological: tPA plus dornase']}], 'interventions': [{'name': 'tPA alone', 'type': 'BIOLOGICAL', 'armGroupLabels': ['tPA alone']}, {'name': 'tPA plus dornase', 'type': 'BIOLOGICAL', 'armGroupLabels': ['tPA plus dornase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Shawn D St. Peter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital and Clinics"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Shawn St. Peter', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}