Comparison of the Effect Between Levofloxacin and Moxifloxacin Among MDR-TB Patients

Overview

Fluoroquinolone is a one of the most important drugs for treatment of multidrug-resistant TB (MDR-TB). Among them, levofloxacin and moxifloxacin has been used most widely. However, there is no study to directly compare the efficacy of levofloxacin and moxifloxacin among MDR-TB patients. The investigators will compare the efficacy of levofloxacin and moxifloxacin through a prospective multicenter randomized open label phase III trial.

Full Title of Study: “Comparison of the Effect Between Levofloxacin and Moxifloxacin on the Culture Conversion After 3 Months Treatment Among MDR-TB Patients; Prospective Multicenter Randomized Open Label Phase III Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2012

Interventions

  • Drug: levofloxacin, moxifloxacin
    • Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months

Arms, Groups and Cohorts

  • Active Comparator: levofloxacin
    • Levofloxacin 750mg po per day for 3 months
  • Active Comparator: moxifloxacin
    • Moxifloxacin 400mg po per day for 3 months

Clinical Trial Outcome Measures

Primary Measures

  • Negative conversion of M. tuberculosis
    • Time Frame: 3 months after initiation of treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with multidrug-resistant TB, but sensitive to levofloxacin and moxifloxacin

Exclusion Criteria

  • Achieved negative conversion of M. TB culture before the enrollment
  • Positive anti-HIV antibody
  • Pregnant women or sexually active women without using proper birth control method
  • Serum creatine grater than 2mg/dL, or urine protein greater than 2+
  • Serum total bilirubin greater than 2 mg/dL or AST and ALT greater than 1.5 times of normal upper limit
  • History or current arrhythmia
  • Hypersensitivity to levofloxacin, moxifloxacin,or rifabutin
  • Should use drug containing metal-ion, warfarin, phenytoin, theophylline, probenecid regularly

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Jae-Joon Yim / Associate Professor, Seoul National University Hospital
  • Overall Official(s)
    • Jae-Joon Yim, MD, Principal Investigator, Seoul National University Hospital

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