Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT03468933
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2018-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fibrinolysis Compared to Thoracoscopy for Pleural Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004653', 'term': 'Empyema'}, {'id': 'D010995', 'term': 'Pleural Diseases'}], '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'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'id': 'D013906', 'term': 'Thoracoscopy'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fkheir@tulane.edu', 'phone': '504-988-3541', 'title': 'Dr. Fayez Kheir', 'organization': 'Tulane University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The perioperative period until hospital discharge, an average of 4 weeks per participant', 'description': 'Definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov.', 'eventGroups': [{'id': 'EG000', 'title': 'Fibrinolytic Therapy Group', 'description': 'Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.\n\ntissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Medical Thoracoscopy Group', 'description': 'Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.\n\nMedical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Respiratory', 'notes': 'Hemothorax without hemodynamic instability and did not need transfusion, but was monitored in the intensive care unit overnight. Intraprocedural hypoxia that resolved with insertion of a supraglottic airway tube and oxygen therapy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Hospital Stay After Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrinolytic Therapy Group', 'description': 'Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.\n\ntissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose'}, {'id': 'OG001', 'title': 'Medical Thoracoscopy Group', 'description': 'Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.\n\nMedical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5.5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 week follow up period', 'description': 'duration of hospital stay in days from time of procedure to discharge from hospital.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received one of the assigned intervention'}, {'type': 'SECONDARY', 'title': 'Total Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrinolytic Therapy Group', 'description': 'Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.\n\ntissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose'}, {'id': 'OG001', 'title': 'Medical Thoracoscopy Group', 'description': 'Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.\n\nMedical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '8.5'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 week follow up period', 'description': 'Total days spent in the hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received assigned intervention'}, {'type': 'SECONDARY', 'title': 'Number of Participants Necessitating Intervention After the Assigned Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrinolytic Therapy Group', 'description': 'Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.\n\ntissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose'}, {'id': 'OG001', 'title': 'Medical Thoracoscopy Group', 'description': 'Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.\n\nMedical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 week follow up period', 'description': '1. Need for surgical intervention (VATS, Open Thoracotomy) in any arm\n2. Need for additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to treatment failure\n3. Need of additional chest tube or additional fibrinolytic doses in the fibrinolytic therapy arm due to treatment failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received assigned intervention'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrinolytic Therapy Group', 'description': 'Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.\n\ntissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose'}, {'id': 'OG001', 'title': 'Medical Thoracoscopy Group', 'description': 'Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.\n\nMedical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 week follow up period', 'description': 'any Adverse events (pain, bleeding)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received assigned intervention'}, {'type': 'SECONDARY', 'title': 'In Hospital and 30-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibrinolytic Therapy Group', 'description': 'Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.\n\ntissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose'}, {'id': 'OG001', 'title': 'Medical Thoracoscopy Group', 'description': 'Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.\n\nMedical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Death of a patient while being hospitalized or up to 30 days after', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received assigned intervention'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fibrinolytic Therapy Group', 'description': 'Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.\n\ntissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose'}, {'id': 'FG001', 'title': 'Medical Thoracoscopy Group', 'description': 'Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.\n\nMedical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fibrinolytic Therapy Group', 'description': 'Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.\n\ntissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose'}, {'id': 'BG001', 'title': 'Medical Thoracoscopy Group', 'description': 'Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.\n\nMedical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '65'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '62.5', 'upperLimit': '72.5'}, {'value': '64', 'groupId': 'BG002', 'lowerLimit': '54.5', 'upperLimit': '69.75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ultrasonographic estimated pleural effusion volume,Moderate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of subjects with community acquired pleural infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-01', 'size': 482433, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-16T12:19', 'hasProtocol': True}, {'date': '2017-07-01', 'size': 163341, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-16T12:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-16', 'studyFirstSubmitDate': '2018-03-05', 'resultsFirstSubmitDate': '2020-12-05', 'studyFirstSubmitQcDate': '2018-03-12', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-16', 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Hospital Stay After Intervention', 'timeFrame': '12 week follow up period', 'description': 'duration of hospital stay in days from time of procedure to discharge from hospital.'}], 'secondaryOutcomes': [{'measure': 'Total Length of Hospital Stay', 'timeFrame': '12 week follow up period', 'description': 'Total days spent in the hospital'}, {'measure': 'Number of Participants Necessitating Intervention After the Assigned Treatment', 'timeFrame': '12 week follow up period', 'description': '1. Need for surgical intervention (VATS, Open Thoracotomy) in any arm\n2. Need for additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to treatment failure\n3. Need of additional chest tube or additional fibrinolytic doses in the fibrinolytic therapy arm due to treatment failure'}, {'measure': 'Adverse Events', 'timeFrame': '12 week follow up period', 'description': 'any Adverse events (pain, bleeding)'}, {'measure': 'In Hospital and 30-day Mortality', 'timeFrame': '30 days', 'description': 'Death of a patient while being hospitalized or up to 30 days after'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pleural Infection', 'Empyema', 'Pleural Diseases', 'Parapneumonic Effusion']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion (CPPE) in adults.', 'detailedDescription': 'Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents one of the most common clinical diagnoses encountered in clinical practice in the United States (US) It is associated with substantial morbidity and mortality despite advances in medical diagnostic and therapeutic strategies.\n\nObjective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy\n\nMethods: Investigators will conduct a prospective randomized clinical trial. Plan is to enroll total of 32 patients and randomize those patients to either Medical Thoracoscopy group or Fibrinolytic Therapy group.\n\nFollow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient setting\n\nPotential Outcome and Benefit: Determine best strategy for treating patients with pleural infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects \\>18 years old with:\n\nEvidence of empyema or complex parapneumonic effusion\n\nExclusion Criteria:\n\nAge \\<18 years Pregnancy Inability to give informed written consent Previous thoracic surgery or thrombolytic therapy for pleural infection Medical thoracoscopy cannot be performed within 48 hours Hemodynamic instability or severe hypoxemia Non corrected coagulopathy Homogeneously echogenic effusion on pleural ultrasonography'}, 'identificationModule': {'nctId': 'NCT03468933', 'briefTitle': 'Fibrinolysis Compared to Thoracoscopy for Pleural Infection', 'organization': {'class': 'OTHER', 'fullName': 'Tulane University'}, 'officialTitle': 'Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '1070390'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fibrinolytic therapy group', 'description': 'Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.', 'interventionNames': ['Drug: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medical Thoracoscopy group', 'description': 'Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.', 'interventionNames': ['Procedure: Medical Thoracoscopy']}], 'interventions': [{'name': 'tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)', 'type': 'DRUG', 'description': 'Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose', 'armGroupLabels': ['Fibrinolytic therapy group']}, {'name': 'Medical Thoracoscopy', 'type': 'PROCEDURE', 'otherNames': ['Pleuroscopy'], 'description': 'Medical thoracoscopy will be performed as per standard protocols.', 'armGroupLabels': ['Medical Thoracoscopy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Medical Center Tulane University Section of Pulmonary DiseasesTulane University Section of Pulmonary Diseases', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Fayez Kheir, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tulane University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tulane University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc', 'investigatorFullName': 'Fayez Kheir,MD,MSc', 'investigatorAffiliation': 'Tulane University'}}}}