Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-10 @ 9:06 PM
Study NCT ID:
NCT01994460
Status:
UNKNOWN
Last Update Posted:
2014-12-30
First Post:
2013-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069349', 'term': 'Linezolid'}, {'id': 'D004977', 'term': 'Ethambutol'}], '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'}, {'id': 'D005029', 'term': 'Ethylenediamines'}, {'id': 'D003959', 'term': 'Diamines'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 429}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-27', 'studyFirstSubmitDate': '2013-11-13', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sputum culture conversion rate on liquid media', 'timeFrame': 'after 2 months of treatment'}], 'secondaryOutcomes': [{'measure': 'Sputum culture conversion rate on solid media', 'timeFrame': 'after 2 months of treatment'}, {'measure': 'Time to sputum culture conversion (liquid and solid media)', 'timeFrame': 'During 6 months of treatment'}, {'measure': 'Cure rate', 'timeFrame': 'After 6 months of treatment'}, {'measure': 'Treatment success rate', 'timeFrame': 'after 6 months of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tuberculosis'], 'conditions': ['Pulmonary Tuberculosis Without Resistance to Rifampicin']}, 'referencesModule': {'references': [{'pmid': '30477961', 'type': 'DERIVED', 'citation': 'Lee JK, Lee JY, Kim DK, Yoon HI, Jeong I, Heo EY, Park YS, Jo YS, Lee JH, Park SS, Park JS, Kim J, Lee SM, Joh JS, Lee CH, Lee J, Choi SM, Park JH, Lee SH, Cho YJ, Lee YJ, Kim SJ, Kwak N, Hwang YR, Kim H, Ki J, Lim JN, Choi HS, Lee M, Song T, Kim HS, Han J, Ahn H, Hahn S, Yim JJ. Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: a prospective, multicentre, randomised, open-label, phase 2 trial. Lancet Infect Dis. 2019 Jan;19(1):46-55. doi: 10.1016/S1473-3099(18)30480-8. Epub 2018 Nov 23.'}, {'pmid': '28193240', 'type': 'DERIVED', 'citation': 'Lee JY, Kim DK, Lee JK, Yoon HI, Jeong I, Heo E, Park YS, Lee JH, Park SS, Lee SM, Lee CH, Lee J, Choi SM, Park JS, Joh JS, Cho YJ, Lee YJ, Kim SJ, Hwang YR, Kim H, Ki J, Choi H, Han J, Ahn H, Hahn S, Yim JJ. Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: study protocol for a prospective, multicenter, randomized, open-label, phase II trial. Trials. 2017 Feb 13;18(1):68. doi: 10.1186/s13063-017-1811-0.'}]}, 'descriptionModule': {'briefSummary': "The current standard short-course treatment for pulmonary TB requires 6 months to complete. This long duration of treatment increases the likelihood of side effects while decreasing patients' adherence to anti-TB drugs. Linezolid showed considerable efficacy against refractory multidrug-resistant TB. Considering the marked anti-TB effects of linezolid as well as the possible adverse effects of its long-term use, it is rational to use linezolid instead of ethambutol for the first 4 weeks of treatment for drug-susceptible pulmonary TB. Through randomized controlled trial, the investigators will evaluate the hypothesis that the use of linezolid instead of ethambutol will increase the sputum culture conversion rate by 15% after 2 months of treatment. Patients with TB without resistance to rifampicin will be randomized to the following three arms at a 1:1:1 ratio: Arma 1 (control arm), Arm 2 (linezolid for 2 weeks instead of ethambutol), Arm 3 (linezolid for 4 weeks instead of ethambutol)Primary outcome will be sputum culture conversion rate after 2 months of treatment (liquid media)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged from 20 to 80 years (20- and 80-year-old patients can participate).\n* Documented sputum Xpert MTB/RIF assay-positive pulmonary TB at screening.\n* On current TB therapy (if any) for ≤14 days at the time of enrollment.\n\nExclusion Criteria:\n\n* Patients with HIV/AIDS.\n* Females of childbearing potential, who are pregnant, breastfeeding, or unwilling to avoid pregnancy.\n* Any of the following:\n\n i.Absolute neutrophil count of \\<2000 cells/mL. ii.White blood cell count (WBC) of \\<3000/μL. iii.Hemoglobin concentration of \\<7.0 g/dL. iv.Serum creatinine level of \\>2.0 mg/dL. v.Aspartate aminotransferase (AST or SGOT) of \\>100 IU/L. vi.Alanine aminotransferase (ALT or SGPT) of \\>100 IU/L. vii.Total bilirubin level of \\>2.0 mg/dL. viii.History of optic neuritis or peripheral neuropathy. ix.Other significant laboratory abnormalities (i.e., absolute neutrophil count, creatinine level).\n\n x.The need for ongoing therapy with SSRIs, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine, buspirone, monoamine oxidase inhibitors (MAOIs), sympathomimetic agents (e.g., pseudoephedrine), vasopressive agents (e.g., epinephrine, norepinephrine), or dopaminergic agents (e.g., dopamine, dobutamine).'}, 'identificationModule': {'nctId': 'NCT01994460', 'briefTitle': 'Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Substitution of Ethambutol With Linezolid During the Intensive Phase of Treatment of Pulmonary Tuberculosis: A Prospective, Multicenter, Randomized, Open-label Phase II Trial', 'orgStudyIdInfo': {'id': 'J-1310-026-523'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 (control arm)', 'description': 'Standard treatment for drug-sensitive pulmonary TB using isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and ethambutol (2 months)', 'interventionNames': ['Drug: Ethambutol']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 (experimental arm 1)', 'description': 'Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 2 weeks)', 'interventionNames': ['Drug: Linezolid']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 (experimental arm 2)', 'description': 'Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 4 weeks)', 'interventionNames': ['Drug: Linezolid']}], 'interventions': [{'name': 'Linezolid', 'type': 'DRUG', 'armGroupLabels': ['Arm 2 (experimental arm 1)', 'Arm 3 (experimental arm 2)']}, {'name': 'Ethambutol', 'type': 'DRUG', 'armGroupLabels': ['Arm 1 (control arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam', 'state': 'Kyunggi', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong Sun Park, MD', 'role': 'CONTACT', 'email': 'jspark.im@gmail.com', 'phone': '031-787-7054'}, {'name': 'Jong Sun Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '100-799', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji Yeon Lee, MD', 'role': 'CONTACT', 'email': 'jedidiah125@gmail.com', 'phone': '82222607284'}, {'name': 'Ji Yeon Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '156-707', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Deog Kyeom Kim, MD', 'role': 'CONTACT', 'email': 'kimdkmd@gmail.com', 'phone': '02-870-2228'}, {'name': 'Deog Kyeom Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jae-Joon Yim, MD', 'role': 'CONTACT', 'email': 'yimjj@snu.ac.kr', 'phone': '82-2-2072-2059'}], 'overallOfficials': [{'name': 'Jae-Joon Yim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health & Welfare, Korea', 'class': 'OTHER_GOV'}, {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jae-Joon Yim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}