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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
Sponsor:
Collaborators:
Ministry of Health & Welfare, Korea
SMG-SNU Boramae Medical Center
Seoul National University Bundang Hospital
Pfizer
Information provided by (Responsible Party):
Jae-Joon Yim, Seoul National University Hospital

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Pulmonary Tuberculosis Without Resistance to Rifampicin Drug: Linezolid Drug: Ethambutol Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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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)
 Drug: Ethambutol
Experimental: Arm 2 (experimental arm 1)
Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 2 weeks)
 Drug: Linezolid
Experimental: Arm 3 (experimental arm 2)
Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 4 weeks)
 Drug: Linezolid


Outcome Measures
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Primary Outcome Measures :
  1. Sputum culture conversion rate on liquid media [ Time Frame: after 2 months of treatment ]

Secondary Outcome Measures :
  1. Sputum culture conversion rate on solid media [ Time Frame: after 2 months of treatment ]
  2. Time to sputum culture conversion (liquid and solid media) [ Time Frame: During 6 months of treatment ]
  3. Cure rate [ Time Frame: After 6 months of treatment ]
  4. Treatment success rate [ Time Frame: after 6 months of treatment ]

Eligibility Criteria
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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
Criteria

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.

  • 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).

Contacts and Locations
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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


Contacts
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Contact: Jae-Joon Yim, MD 82-2-2072-2059 yimjj@snu.ac.kr

Locations
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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         
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Health & Welfare, Korea
SMG-SNU Boramae Medical Center
Seoul National University Bundang Hospital
Pfizer
Investigators
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Principal Investigator: Jae-Joon Yim, MD Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Jae-Joon Yim, Seoul National University Hospital:
Tuberculosis
Additional relevant MeSH terms:
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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