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

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Fluoroquinolones; Levofloxacin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ofloxacin

Criteria

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