Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis
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ClinicalTrials.gov Identifier: NCT01994460 |
Recruitment Status : Unknown
Verified December 2014 by Jae-Joon Yim, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : November 25, 2013
Last Update Posted : December 30, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Tuberculosis Without Resistance to Rifampicin | Drug: Linezolid Drug: Ethambutol | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 429 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Substitution of Ethambutol With Linezolid During the Intensive Phase of Treatment of Pulmonary Tuberculosis: A Prospective, Multicenter, Randomized, Open-label Phase II Trial |
Study Start Date : | January 2014 |
Estimated Primary Completion Date : | December 2015 |
Estimated Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Arm 1 (control arm)
Standard treatment for drug-sensitive pulmonary TB using isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and ethambutol (2 months)
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Drug: Ethambutol |
Experimental: Arm 2 (experimental arm 1)
Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 2 weeks)
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Drug: Linezolid |
Experimental: Arm 3 (experimental arm 2)
Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 4 weeks)
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Drug: Linezolid |
- Sputum culture conversion rate on liquid media [ Time Frame: after 2 months of treatment ]
- Sputum culture conversion rate on solid media [ Time Frame: after 2 months of treatment ]
- Time to sputum culture conversion (liquid and solid media) [ Time Frame: During 6 months of treatment ]
- Cure rate [ Time Frame: After 6 months of treatment ]
- Treatment success rate [ Time Frame: after 6 months of treatment ]

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females aged from 20 to 80 years (20- and 80-year-old patients can participate).
- Documented sputum Xpert MTB/RIF assay-positive pulmonary TB at screening.
- On current TB therapy (if any) for ≤14 days at the time of enrollment.
Exclusion Criteria:
- Patients with HIV/AIDS.
- Females of childbearing potential, who are pregnant, breastfeeding, or unwilling to avoid pregnancy.
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Any of the following:
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).
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994460
Contact: Jae-Joon Yim, MD | 82-2-2072-2059 | yimjj@snu.ac.kr |
Korea, Republic of | |
Seoul National University Bundang Hospital | Recruiting |
Seongnam, Kyunggi, Korea, Republic of, 463-707 | |
Contact: Jong Sun Park, MD 031-787-7054 jspark.im@gmail.com | |
Principal Investigator: Jong Sun Park, MD | |
National Medical Center | Recruiting |
Seoul, Korea, Republic of, 100-799 | |
Contact: Ji Yeon Lee, MD 82222607284 jedidiah125@gmail.com | |
Principal Investigator: Ji Yeon Lee, MD | |
SMG-SNU Boramae Medical Center | Recruiting |
Seoul, Korea, Republic of, 156-707 | |
Contact: Deog Kyeom Kim, MD 02-870-2228 kimdkmd@gmail.com | |
Principal Investigator: Deog Kyeom Kim, MD |
Principal Investigator: | Jae-Joon Yim, MD | Seoul National University Hospital |
Responsible Party: | Jae-Joon Yim, Professor, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT01994460 |
Other Study ID Numbers: |
J-1310-026-523 |
First Posted: | November 25, 2013 Key Record Dates |
Last Update Posted: | December 30, 2014 |
Last Verified: | December 2014 |
Tuberculosis |
Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Linezolid Ethambutol Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antitubercular Agents |