Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT00502632
Status:
UNKNOWN
Last Update Posted:
2008-05-12
First Post:
2007-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dornase Alfa and Urokinase for Kids With Pleural Empyema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016724', 'term': 'Empyema, Pleural'}, {'id': 'D010996', 'term': 'Pleural Effusion'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004653', 'term': 'Empyema'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014568', 'term': 'Urokinase-Type Plasminogen Activator'}, {'id': 'C568813', 'term': 'dornase alfa'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-05-09', 'studyFirstSubmitDate': '2007-07-16', 'studyFirstSubmitQcDate': '2007-07-16', 'lastUpdatePostDateStruct': {'date': '2008-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of hospital stay', 'timeFrame': 'From beginning of intrapleural treatment'}, {'measure': 'Need for additional surgical procedures', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Duration of suction applied to chest drain', 'timeFrame': 'From beginning of intrapleural treatment'}, {'measure': 'Duration of fever', 'timeFrame': 'From beginning of intrapleural treatment'}, {'measure': 'Duration of intravenous antibiotic treatment', 'timeFrame': 'From beginning of intrapleural treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pleural empyema', 'Pleural effusion', 'Dornase alfa', 'Urokinase', 'Children'], 'conditions': ['Pleural Empyema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intrapleural treatment with Dornase alfa plus Urokinase improves clinical outcome compared to Urokinase alone in children with complicated parapneumonic effusions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 1 year and \\< 16 years\n* Respiratory infection (pneumonia or lung abscess)\n* Effusion occupying at least 1/3 of hemithorax on chest X-ray\n* Complicated effusion (presence of at least one of the following):\n\n * Hyperechoic pleural fluid on chest US scan\n * Loculated collection on chest US or CT scan\n * Purulent pleural fluid\n * Positive culture or Gram stain on pleural fluid\n\nExclusion Criteria:\n\n* Non parapneumonic effusion\n* Immunodeficiency\n* Neurological impairment\n* Suspected or proven allergy to Urokinase or Dornase alfa\n* Suspected or documented bronchopleural fistula\n* Impaired coagulation (INR\\>2), haemorrhage, high risk for bleeding\n* Thoracic surgical procedure (e.g. thoracoscopy, mini-thoracotomy) already performed\n* Chest drain inserted since 6 or more days'}, 'identificationModule': {'nctId': 'NCT00502632', 'acronym': 'DUKE', 'briefTitle': 'Dornase Alfa and Urokinase for Kids With Pleural Empyema', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera di Padova'}, 'officialTitle': 'Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children', 'orgStudyIdInfo': {'id': '1372P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Intrapleural administration of:\n\n* Urokinase 40,000 in 40ml normal saline, twice daily for 4 days\n* Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days', 'interventionNames': ['Drug: Urokinase and Dornase alfa']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Intrapleural administration of:\n\n* Urokinase 40,000 in 40ml normal saline, twice daily for 4 days\n* 25ml normal saline, twice daily for 4 days', 'interventionNames': ['Drug: Urokinase']}], 'interventions': [{'name': 'Urokinase and Dornase alfa', 'type': 'DRUG', 'description': 'Intrapleural administration of:\n\n* Urokinase 40,000 in 40ml normal saline, twice daily for 4 days\n* Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days', 'armGroupLabels': ['1']}, {'name': 'Urokinase', 'type': 'DRUG', 'description': 'Intrapleural administration of:\n\n* Urokinase 40,000 in 40ml normal saline, twice daily for 4 days\n* 25ml normal saline, twice daily for 4 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24128', 'city': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maurizio Cheli, MD', 'role': 'CONTACT', 'email': 'mauriziocheli@tin.it'}, {'name': 'Maurizio Cheli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedali Riuniti di Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '35128', 'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'PierGiorgio Gamba, MD', 'role': 'CONTACT', 'email': 'piergiorgio.gamba@unipd.it', 'phone': '+39 049 821 3683'}, {'name': 'Eleonora Cesca, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sonia Viale, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '00165', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Inserra, MD', 'role': 'CONTACT', 'email': 'lobina@opbg.net', 'phone': '+39 06 6859 2423'}, {'name': 'Alessandro Inserra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Ospedale Bambino Gesu'", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'PierGiorgio Gamba, MD', 'role': 'CONTACT', 'email': 'piergiorgio.gamba@unipd.it', 'phone': '+39 049 821 3683'}], 'overallOfficials': [{'name': 'PierGiorgio Gamba, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Azienda Ospedaliera di Padova'}, {'name': 'Giorgio Stefanutti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Women's and Children's Hospital, Adelaide, SA"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera di Padova', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr PierGiorgio Gamba', 'oldOrganization': 'Azienda Ospedaliera di Padova'}}}}