Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT03898635
Status:
UNKNOWN
Last Update Posted:
2019-04-02
First Post:
2019-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014390', 'term': 'Tuberculosis, Meningeal'}], 'ancestors': [{'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020306', 'term': 'Tuberculosis, Central Nervous System'}, {'id': 'D000092225', 'term': 'Tuberculosis, Extrapulmonary'}, {'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-29', 'studyFirstSubmitDate': '2019-03-28', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time of Glasgow Coma Scale recovered to 15', 'timeFrame': 'From the beginning of anti-tuberculosis treatment to the first documented recovery, assessed up to 5 years.'}, {'measure': 'Time of body temperature returns to normal', 'timeFrame': 'From the beginning of anti-tuberculosis treatment to the first documented recovery, assessed up to 5 years.'}, {'measure': 'Number of participants with new omplications', 'timeFrame': 'From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years.', 'description': 'Hydrocephalus, cerebral infarction, epilepsy, brain abscess, tuberculoma'}], 'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Medical Research Council grade deterioration', 'timeFrame': 'From the beginning of anti-tuberculosis treatment to the first documented progression, assessed up to 5 years.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['linezolid'], 'conditions': ['Tuberculous Meningitis']}, 'descriptionModule': {'briefSummary': 'Tuberculous meningitis (TBM) is the most serious form of Mycobacterium tuberculosis infection, causing mortality and disability in more than half of the patients. Current standard treatment for TBM is based on those developed to treat pulmonary tuberculosis, which does not take into account the differential ability of anti-tuberculosis drugs to penetrate the brain. With both good central nervous system penetrance and anti-tuberculosis efficacy that have been demonstrated in drug-resistant tuberculosis, linezolid may be a promising antimicrobial in TBM treatment. The purpose of this study is to evaluate the effectiveness of linezolid in the treatment of TBM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with central nervous system tuberculosis diagnosed and treated at Huashan Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients diagnosed as TBM from the electronic medical record system.\n\nExclusion Criteria:\n\n* Does not meet the established diagnostic criteria;\n* Combine other pathogen central infections;\n* Follow-up confirmed that the final diagnosis considers other diseases (such as tumors, autoimmune encephalitis, etc.);\n* Our hospital has less than one week of anti-tuberculosis treatment;\n* Lack of information'}, 'identificationModule': {'nctId': 'NCT03898635', 'briefTitle': 'Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis', 'orgStudyIdInfo': {'id': '2017-44'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Background group', 'description': 'The treatment regimen does not include linezolid throughout the treatment course.'}, {'label': 'Background-linezolid group', 'description': 'Linezolid was added in the middle of the treatment course but not in the initial treatment regimen.', 'interventionNames': ['Drug: Linezolid']}, {'label': 'Linezolid initial group', 'description': 'Linezolid was in initial treatment regimen.', 'interventionNames': ['Drug: Linezolid']}], 'interventions': [{'name': 'Linezolid', 'type': 'DRUG', 'description': 'To add linezolid 600mg or 1200mg daily in the initial or subsequent treatment regimen of TBM.', 'armGroupLabels': ['Background-linezolid group', 'Linezolid initial group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenhong Zhang', 'role': 'CONTACT', 'email': 'zhangwenhong@fudan.edu.cn', 'phone': '(86)52889999'}], 'facility': 'Infectious department of Huashan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xian Zhou', 'role': 'CONTACT', 'email': 'zhouxian-13@163.com', 'phone': '(86)18801734036'}, {'name': 'Feng Sun', 'role': 'CONTACT', 'email': 'aaronsf1125@126.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Division of Infectious Diseases', 'investigatorFullName': 'Wen-hong Zhang', 'investigatorAffiliation': 'Huashan Hospital'}}}}