Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT00338793
Status:
COMPLETED
Last Update Posted:
2008-08-26
First Post:
2006-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corticosteroids in the Treatment of Tuberculous Pleurisy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014396', 'term': 'Tuberculosis, Pleural'}, {'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D010996', 'term': 'Pleural Effusion'}], 'ancestors': [{'id': 'D000092225', 'term': 'Tuberculosis, Extrapulmonary'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-25', 'studyFirstSubmitDate': '2006-06-19', 'studyFirstSubmitQcDate': '2006-06-19', 'lastUpdatePostDateStruct': {'date': '2008-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death'}, {'measure': 'Presence of pleural thickening'}, {'measure': 'Pulmonary function at completion of treatment'}, {'measure': 'Adverse drug effects'}], 'secondaryOutcomes': [{'measure': 'Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)'}, {'measure': 'Reabsorption of pleural effusion'}, {'measure': 'Failure rate at the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tuberculosis;', 'Pleural effusion;', 'Corticosteroids.'], 'conditions': ['Tuberculous Pleurisy']}, 'descriptionModule': {'briefSummary': 'Tuberculous pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids are used for tuberculous pleurisy because their anti-inflammatory effect is thought to minimise pleural reactivity and thereby reduce residual pleural thickening. The purpose is to evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with tuberculous pleurisy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent;\n* Presented with clinical features suggesting pleural tuberculosis;\n* Had not previously received treatment or prophylaxis for tuberculosis;\n* Had not recently received treatment with glucocorticoids;\n* Were not pregnant or breast-feeding.\n\nExclusion Criteria:\n\n* Failed to complete the screening procedures;\n* Were seropositive for HIV\n* Tuberculous meningitis;\n* Had risk factors for serious steroid-related adverse events (a history of diabetes or positive urine glucose, a history or clinical finding of hypertension, or a history of peptic ulcer disease or mental illness);\n* Standard doses of antituberculosis drugs could not be used (as in participants with concurrent liver disease)\n* Psychiatric illness;\n* Alcoholism.'}, 'identificationModule': {'nctId': 'NCT00338793', 'briefTitle': 'Corticosteroids in the Treatment of Tuberculous Pleurisy', 'organization': {'class': 'OTHER', 'fullName': 'Guangxi Medical University'}, 'officialTitle': 'A Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Corticosteroids for Treatment of Patients With Tuberculous Pleurisy', 'orgStudyIdInfo': {'id': 'Shi-TB-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'prednisolone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Huan-Zhong Shi', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}], 'overallOfficials': [{'name': 'Huan-Zhong Shi, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Respiratory Diseases, First Affiliated Hospital, Guangxi Medical University, Nanning 530021, Guangxi, China'}, {'name': 'Zhan-Cheng Gao, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Respiratory Diseases, People's Hospital, Peking University, Beijing, China"}, {'name': 'Xin Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Respiratory Diseases, First Affiliated Hospital, Shanghai Jiaotong University, Shanghai, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangxi Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}, {'name': 'Ministry of Education, China', 'class': 'OTHER_GOV'}, {'name': 'Bureau of Science and Technology of Guangxi Province, China', 'class': 'UNKNOWN'}]}}}