Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-29 @ 8:24 AM
Study NCT ID:
NCT00103766
Status:
UNKNOWN
Last Update Posted:
2006-08-01
First Post:
2005-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004653', 'term': 'Empyema'}, {'id': 'D010996', 'term': 'Pleural Effusion'}], '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': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-10'}, 'statusVerifiedDate': '2006-07', 'lastUpdateSubmitDate': '2006-07-31', 'studyFirstSubmitDate': '2005-02-14', 'studyFirstSubmitQcDate': '2005-02-14', 'lastUpdatePostDateStruct': {'date': '2006-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.'}], 'secondaryOutcomes': [{'measure': 'Mortality'}, {'measure': 'Hospital length of stay'}, {'measure': 'Daily chest tube drainage'}, {'measure': 'Radiographic improvement'}]}, 'conditionsModule': {'keywords': ['Alteplase', 'Empyema', 'Complicated Parapneumonic Effusion'], 'conditions': ['Empyema', 'Pleural Effusion']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the benefit to patients with empyema or complicated parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two different dose strategies compared with saline placebo.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled pilot study. Patients with empyema and complicated parapneumonic effusion who are felt to require fibrinolytic therapy will be considered for study enrollment. Enrolled patients will be randomized to one of five potential treatment arms (saline placebo, 4 mg once daily, 4 mg twice daily, 10 mg once daily, or 10 mg twice daily) in a double-blinded manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written informed consent\n* Age greater or equal to 18 yrs\n* Presence of empyema or CPE\n\nExclusion Criteria:\n\n* Active internal bleeding\n* Pregnancy\n* Prior enrollment in this study\n* Platelet count less than 100,000/mm3\n* Use of warfarin sodium if INR is greater than 1.7\n* Use of heparin unless the PTT is less than 1.5 times baseline normal\n* Known neurological disorders\n* Current or pre-existing bleeding dyscrasia\n* Known allergy to Alteplase'}, 'identificationModule': {'nctId': 'NCT00103766', 'briefTitle': 'Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion', 'organization': {'class': 'INDIV', 'fullName': "O'Brien, Jeana D., MD, FACP, FCCP"}, 'officialTitle': 'Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion', 'orgStudyIdInfo': {'id': '8736'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Alteplase', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Delores Gautier, RN, MSN', 'role': 'CONTACT', 'email': 'lgautier@swmail.sw.org', 'phone': '254-724-1769'}, {'name': "Jeana D O'Brien, MD, FACP, FCCP", 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dominic R deKeratry, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Timothy S Mooring, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Scott and White Memorial Hospital & Clinic', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}], 'centralContacts': [{'name': 'Delores Gautier, RN, MSN', 'role': 'CONTACT', 'email': 'lgautier@swmail.sw.org', 'phone': '254-724-1769'}], 'overallOfficials': [{'name': "Jeana D O'Brien, MD, FACP, FCCP", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "O'Brien, Jeana D., MD, FACP, FCCP", 'class': 'INDIV'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'Scott and White Hospital & Clinic', 'class': 'OTHER'}, {'name': 'Scott, Sherwood and Brindley Foundation', 'class': 'OTHER'}, {'name': 'Texas A&M University', 'class': 'OTHER'}]}}}