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

Seoul National University

Status and phase: Terminated; Phase 3

Conditions: TB

Treatments: Drug: levofloxacin, moxifloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01055145

H-0911-068-301

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

levofloxacin

Active Comparator group

Description:

Levofloxacin 750mg po per day for 3 months

Treatment:

Drug: levofloxacin, moxifloxacin

moxifloxacin

Active Comparator group

Description:

Moxifloxacin 400mg po per day for 3 months

Treatment:

Drug: levofloxacin, moxifloxacin