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Trial record 1 of 1 for:    NCT01994460
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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

Tracking Information
First Submitted Date  ICMJE November 13, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date December 30, 2014
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Sputum culture conversion rate on liquid media [ Time Frame: after 2 months of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis
Official Title  ICMJE Substitution of Ethambutol With Linezolid During the Intensive Phase of Treatment of Pulmonary Tuberculosis: A Prospective, Multicenter, Randomized, Open-label Phase II Trial
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Tuberculosis Without Resistance to Rifampicin
Intervention  ICMJE
  • Drug: Linezolid
  • Drug: Ethambutol
Study Arms  ICMJE
  • 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)
    Intervention: Drug: Ethambutol
  • Experimental: Arm 2 (experimental arm 1)
    Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 2 weeks)
    Intervention: Drug: Linezolid
  • Experimental: Arm 3 (experimental arm 2)
    Isoniazid (6 months), rifampicin (6 months), pyrazinamide (2 months), and linezolid (600 mg/day, 4 weeks)
    Intervention: Drug: Linezolid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 19, 2013)
429
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994460
Other Study ID Numbers  ICMJE J-1310-026-523
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jae-Joon Yim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Ministry of Health & Welfare, Korea
  • SMG-SNU Boramae Medical Center
  • Seoul National University Bundang Hospital
  • Pfizer
Investigators  ICMJE
Principal Investigator: Jae-Joon Yim, MD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP