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

Phase 3TerminatedNCT01055145

Seoul National University Hospital182 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

182

Conditions

Interventions

levofloxacin, moxifloxacinDRUG

Levofloxacin 750mg po per day for 3 months vs. Moxifloxacin 400mg po per day for 3 months

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (29)

Outcomes

Primary Outcomes

Negative conversion of M. tuberculosis

Time frame: 3 months after initiation of treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.